Paravalvular sealing via extended cuff mechanisms

ABSTRACT

A prosthetic heart valve  300  may include a collapsible and expandable stent  306  having a proximal end  302 , a distal end  304 , an annulus section adjacent the proximal end, and a plurality of cells connected to one another in annular rows around the stent, a cuff  312  attached to the stent, and a sealing member  322  attached to the cuff and extending from a proximal end  313  of the cuff to a free edge  323 . The sealing member  322  may be movable between an extended condition in which the free edge  323  is located proximally of the proximal end  302  of the stent  306 , and an inverted condition in which the free edge is located distally of the proximal end of the stent and a first surface  324  of the sealing member confronts an outward-facing surface of the cuff. Various mechanisms for moving the sealing member  322  are also described.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of the filing date of U.S.Provisional Patent Application No. 61/972,831 filed Mar. 31, 2014, thedisclosure of which is hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present disclosure relates in general to heart valve replacementand, in particular, to collapsible prosthetic heart valves. Moreparticularly, the present disclosure relates to devices and methods forpositioning and sealing collapsible prosthetic heart valves within anative valve annulus.

Prosthetic heart valves that are collapsible to a relatively smallcircumferential size can be delivered into a patient less invasivelythan valves that are not collapsible. For example, a collapsible valvemay be delivered into a patient via a tube-like delivery apparatus suchas a catheter, a trocar, a laparoscopic instrument, or the like. Thiscollapsibility can avoid the need for a more invasive procedure such asfull open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valvestructure mounted on a stent. There are two common types of stents onwhich the valve structures are ordinarily mounted: a self-expandingstent or a balloon-expandable stent. To place such valves into adelivery apparatus and ultimately into a patient, the valve must firstbe collapsed or crimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant sitein the patient (e.g., at or near the annulus of the patient's heartvalve that is to be replaced by the prosthetic valve), the prostheticvalve can be deployed or released from the delivery apparatus andre-expanded to full operating size. For balloon-expandable valves, thisgenerally involves releasing the entire valve, and then expanding aballoon positioned within the valve stent. For self-expanding valves, onthe other hand, the stent automatically expands as the sheath coveringthe valve is withdrawn.

BRIEF SUMMARY OF THE INVENTION

Described herein is a prosthetic heart valve configured to be expandedproximate a native valve of a patient. The prosthetic heart valve mayinclude a collapsible and expandable stent having a proximal end, adistal end, an annulus section adjacent the proximal end, and aplurality of cells connected to one another in a plurality of annularrows around the stent, a cuff attached to the annulus section of thestent and defining an outward-facing surface, a plurality of prostheticvalve leaflets attached to the cuff, and a sealing member attached tothe cuff and extending from a proximal end of the cuff to a free edge.The stent may have a flow direction extending from the proximal end ofthe stent toward the distal end of the stent. The sealing member may bemovable between an extended condition in which the free edge is locatedproximally of the proximal end of the stent, and an inverted conditionin which the free edge is located distally of the proximal end of thestent and a first surface of the sealing member confronts theoutward-facing surface of the cuff.

Also described herein is another prosthetic heart valve configured to beexpanded proximate a native valve of a patient. The prosthetic heartvalve may include a collapsible and expandable stent having a proximalend, a distal end, an annulus section adjacent the proximal end, and aplurality of cells connected to one another in a plurality of annularrows around the stent, a cuff attached to the annulus section of thestent and defining an outward-facing surface, a plurality of prostheticvalve leaflets attached to the cuff, and a sealing member attached tothe cuff and extending from a proximal end of the cuff to a free edge.The stent may have a flow direction extending from the proximal end ofthe stent toward the distal end of the stent. The sealing member may bemovable between an extended condition in which the free edge is locateda first distance proximally of the proximal end of the stent, and acompressed condition in which the free edge is located a second distanceproximally of the proximal end of the stent.

Also described herein is a method of expanding a prosthetic heart valveproximate a native valve of a patient. The prosthetic heart valve mayinclude a stent having proximal and distal ends, a cuff attached to thestent, and a sealing member extending from a proximal end of the cuff toa free edge.

The method may include collapsing the prosthetic heart valve into adelivery device such that the sealing member is in an extended conditionin which the free edge is located proximally of the proximal end of thestent, inserting the delivery device into a patient, advancing thedelivery device proximate an annulus of the native valve, partiallyexpanding the prosthetic heart valve in a selected position proximatethe native valve, moving the sealing member from the extended conditionto an inverted condition in which the free edge is located distally ofthe proximal end of the stent, and fully expanding the prosthetic heartvalve.

Also described herein is a system including a delivery device and aprosthetic heart valve. The delivery device may include an operatinghandle and a catheter assembly. The catheter assembly may include afirst shaft around which a compartment is defined, the first shaft beingoperatively connected to the operating handle, and a distal sheath atleast partially surrounding the first shaft, the distal sheath beingmoveable between a closed condition covering the compartment and an opencondition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. Theprosthetic valve may include a collapsible and expandable stent, a cuff,and a sealing member attached to the cuff. The stent may have a proximalend, a distal end, and an annulus section adjacent the proximal end, thestent having a flow direction extending from the proximal end toward thedistal end. The cuff may be attached to the annulus section of the stentand may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a freeedge, the sealing member being movable between an extended condition inwhich the free edge is located at a first location proximally of theproximal end of the stent, and a use condition in which the free edge islocated at a second location distally of the first location and a firstsurface of the sealing member confronts the outward-facing surface ofthe cuff. The sealing member may have an energy storage element with abias to move the sealing member toward the use condition. The catheterassembly may have a restraining member removably coupled to the sealingmember to hold the sealing member in the extended condition against thebias of the energy storage element.

Also described herein is a system including a delivery device and aprosthetic heart valve. The delivery device may include an operatinghandle and a catheter assembly. The catheter assembly may include afirst shaft around which a compartment is defined, the first shaft beingoperatively connected to the operating handle, and a distal sheath atleast partially surrounding the first shaft, the distal sheath beingmoveable between a closed condition covering the compartment and an opencondition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. Theprosthetic valve may include a collapsible and expandable stent, a cuff,and a sealing member attached to the cuff. The stent may have a proximalend, a distal end, and an annulus section adjacent the proximal end, thestent having a flow direction extending from the proximal end toward thedistal end. The cuff may be attached to the annulus section of the stentand may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a freeedge, the sealing member being movable between an extended condition inwhich the free edge is located at a first location proximally of theproximal end of the stent, and a use condition in which the free edge islocated at a second location distally of the first location and a firstsurface of the sealing member confronts the outward-facing surface ofthe cuff. The catheter assembly may have an actuating filament having aportion removably coupled to the sealing member and configured to movethe sealing member from the extended condition to the use condition whenthe portion of the actuating filament is moved toward the operatinghandle.

Also described herein is a system including a delivery device and aprosthetic heart valve. The delivery device may include an operatinghandle and a catheter assembly. The catheter assembly may include afirst shaft around which a compartment is defined, the first shaft beingoperatively connected to the operating handle, and a distal sheath atleast partially surrounding the first shaft, the distal sheath beingmoveable between a closed condition covering the compartment and an opencondition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. Theprosthetic valve may include a collapsible and expandable stent, a cuff,and a sealing member attached to the cuff. The stent may have a proximalend, a distal end, and an annulus section adjacent the proximal end, thestent having a flow direction extending from the proximal end toward thedistal end. The cuff may be attached to the annulus section of the stentand may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a freeedge, the sealing member being movable between an extended condition inwhich the free edge is located at a first location proximally of theproximal end of the stent, and a use condition in which the free edge islocated at a second location distally of the first location and a firstsurface of the sealing member confronts the outward-facing surface ofthe cuff. The catheter assembly may have an actuating filament removablycoupled to a retaining element of the catheter assembly and configuredto move the sealing member from the extended condition to the usecondition when a portion of the actuating filament is moved toward theoperating handle.

Also described herein is a system including a delivery device and aprosthetic heart valve. The delivery device may include an operatinghandle and a catheter assembly. The catheter assembly may include afirst shaft around which a compartment is defined, the first shaft beingoperatively connected to the operating handle, and a distal sheath atleast partially surrounding the first shaft, the distal sheath beingmoveable between a closed condition covering the compartment and an opencondition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. Theprosthetic valve may include a collapsible and expandable stent, a cuff,a sealing member attached to the cuff, an expandable anchor portionhaving a generally cylindrical shape, and an actuating filament. Thestent may have a proximal end, a distal end, and an annulus sectionadjacent the proximal end, the stent having a flow direction extendingfrom the proximal end toward the distal end. The cuff may be attached tothe annulus section of the stent and may define an outward-facingsurface.

The sealing member may extend from a proximal end of the cuff to a freeedge, the sealing member being movable between an extended condition inwhich the free edge is located at a first location proximally of theproximal end of the stent, and a use condition in which the free edge islocated at a second location distally of the first location and a firstsurface of the sealing member confronts the outward-facing surface ofthe cuff. The actuating filament may extend between the free edge of thesealing member and the expandable anchor portion, the actuating filamentconfigured to move the sealing member from the extended condition to theuse condition when the expandable anchor portion is moved toward theoperating handle.

Also described herein is a method of expanding a prosthetic heart valveproximate a native valve of a patient. The prosthetic heart valve mayinclude a stent having proximal and distal ends, a cuff attached to thestent, and a sealing member extending from a proximal end of the cuff toa free edge.

The method may include collapsing the prosthetic heart valve into adelivery device such that the sealing member is in an extended conditionin which the free edge is located proximally of the proximal end of thestent, inserting the delivery device into a patient, advancing thedelivery device proximate an annulus of the native valve, expanding theprosthetic heart valve from a first diameter to a second diametergreater than the first diameter in a selected position proximate thenative valve, and moving the sealing member from the extended conditionto a use condition in which the free edge is located at a secondlocation distally of the first location.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of heart valves are disclosed herein with referenceto the drawings, wherein:

FIG. 1 is a side elevational view of a conventional prosthetic heartvalve;

FIG. 2A is a highly schematic cross-sectional view taken along line A-Aof FIG. 1 and showing the prosthetic heart valve disposed within anative valve annulus;

FIG. 2B is a highly schematic cross-sectional view showing a prostheticmitral valve disposed within a native valve annulus;

FIG. 3A is a side view of an embodiment of a prosthetic heart valvehaving a sealing member for filling irregularities between the heartvalve and the native valve annulus in accordance with the presentdisclosure, with the sealing member in an extended condition;

FIG. 3B is a side view of the prosthetic heart valve of FIG. 3A, withthe sealing member in an inverted condition;

FIG. 3C is a highly schematic perspective view of the cuff and sealingmember of FIG. 3B;

FIGS. 4A-4F are perspective views showing stages of deployment of theprosthetic heart valve of FIG. 3A;

FIG. 5A is a side view of another embodiment of a prosthetic heart valvehaving a sealing ring for filling irregularities between the heart valveand the native valve annulus in accordance with the present disclosure,with the sealing ring in the inverted condition;

FIG. 5B is a highly schematic perspective view of the prosthetic heartvalve of FIG. 5A, with the sealing ring in the extended condition;

FIG. 5C is a side view of another embodiment of a prosthetic heart valvehaving two sealing rings for filling irregularities between the heartvalve and the native valve annulus;

FIGS. 5D-5G are highly schematic perspective views of alternativesealing ring embodiments that can be used with the stent, cuff, sealingmember, and leaflets of the embodiment of FIGS. 5A-5C;

FIG. 5H is a highly schematic cross-sectional view of an alternativesealing ring feature that can be used with any of the sealing ringembodiments of FIGS. 5A-5G;

FIG. 6A is a perspective view of another embodiment of a prostheticheart valve having a sealing ring for filling irregularities between theheart valve and the native valve annulus in accordance with the presentdisclosure;

FIG. 6B is a highly schematic top view of the sealing ring of FIG. 6A,without the other heart valve structures;

FIGS. 6C-6F are highly schematic top views of alternative sealing ringembodiments that can be used with the stent, cuff, and leaflets of FIG.6A;

FIG. 7A is a highly schematic side view of an embodiment of a prostheticheart valve having a sealing member for filling irregularities betweenthe heart valve and the native valve annulus in accordance with thepresent disclosure, with the sealing member in a contracted condition;

FIG. 7B is a highly schematic partial cross-sectional view of thesealing member of FIG. 7A, with the sealing member in an extendedcondition;

FIG. 7C is a highly schematic partial cross-sectional view of thesealing member of FIG. 7A, with the sealing member in the contractedcondition;

FIG. 7D is a highly schematic partial cross-sectional view of avariation of the sealing member of FIG. 7A, with the sealing member inan extended condition;

FIG. 7E is a highly schematic partial cross-sectional view of avariation of the sealing member of FIG. 7A, with the sealing member in acontracted condition;

FIG. 8A is a highly schematic side view of an embodiment of a prostheticheart valve having a sealing member for filling irregularities betweenthe heart valve and the native valve annulus in accordance with thepresent disclosure, with the sealing member in an extended condition;

FIG. 8B is a highly schematic side view of the prosthetic heart valve ofFIG. 8A, with the sealing member in an inverted condition;

FIG. 8C is a highly schematic side view of the prosthetic heart valve ofFIG. 8A, with the sealing member in a contracted condition;

FIG. 9A is a partial highly schematic side view of an embodiment of aprosthetic heart valve having a sealing member for fillingirregularities between the heart valve and the native valve annulus inaccordance with the present disclosure, with the sealing member in anextended condition;

FIG. 9B is a partial highly schematic side view of the prosthetic heartvalve of FIG. 9A, with the sealing member in a rolled condition;

FIG. 10A is a top plan view of a portion of an operating handle for atransfemoral delivery device for a collapsible prosthetic heart valve,shown with a partial longitudinal cross-section of the distal portion ofa transfemoral catheter assembly;

FIG. 10B is a side view of the handle of FIG. 1A;

FIG. 10C is a perspective view of an embodiment of a prosthetic heartvalve suitable for use with the operating handle of FIG. 10A;

FIG. 11 is a highly schematic side view of an embodiment of a prostheticheart valve having a sealing member for filling irregularities betweenthe heart valve and the native valve annulus in accordance with thepresent disclosure, with the sealing member in an extended condition;

FIG. 12A is a highly schematic cross-sectional view of an embodiment ofa prosthetic heart valve having a sealing member for fillingirregularities between the heart valve and the native valve annulus inaccordance with the present disclosure, with the sealing member in anextended condition, shown in the distal end of a delivery device;

FIG. 12B is a highly schematic cross-sectional view of the prostheticheart valve and distal end of the delivery device of FIG. 12A, with thesealing member in a contracted condition;

FIG. 12C is a highly schematic cross-sectional view of the prostheticheart valve of FIG. 12A, with the prosthetic heart valve released fromthe delivery device;

FIG. 13A is a highly schematic cross-sectional view of an embodiment ofa prosthetic heart valve having a sealing member for fillingirregularities between the heart valve and the native valve annulus inaccordance with the present disclosure, with the sealing member in aninverted condition, shown coupled to the distal end of a deliverydevice;

FIG. 13B is a highly schematic cross-sectional view of a variant of theprosthetic heart valve and distal end of the delivery device of FIG.13A, with the sealing member in an inverted condition;

FIG. 14A is a highly schematic cross-sectional view of an embodiment ofa prosthetic heart valve having a sealing member for fillingirregularities between the heart valve and the native valve annulus inaccordance with the present disclosure, with the sealing member in anextended condition;

FIG. 14B is a highly schematic cross-sectional view of the prostheticheart valve of FIG. 14A, with the sealing member in an invertedcondition;

FIG. 15A is a highly schematic cross-sectional view of an embodiment ofa prosthetic heart valve having a sealing member for fillingirregularities between the heart valve and the native valve annulus inaccordance with the present disclosure, with the sealing member in anextended condition, shown coupled to the distal end of a deliverydevice;

FIG. 15B is a highly schematic cross-sectional view of the prostheticheart valve and distal end of the delivery device of FIG. 15A, with thesealing member in an inverted condition;

FIG. 16A is a highly schematic cross-sectional view of an embodiment ofa prosthetic heart valve having a sealing member for fillingirregularities between the heart valve and the native valve annulus inaccordance with the present disclosure, with the sealing member in aninverted condition, shown coupled to the distal end of a deliverydevice;

FIG. 16B is a highly schematic cross-sectional view of a variant of theprosthetic heart valve of FIG. 16A, with the sealing member in aninverted condition;

FIG. 16C is a highly schematic cross-sectional view of another variantof the prosthetic heart valve of FIG. 16A, with the sealing member in aninverted condition, shown coupled to the distal end of a deliverydevice;

FIG. 17 is a highly schematic cross-sectional view of an embodiment of aprosthetic heart valve having a sealing member for fillingirregularities between the heart valve and the native valve annulus inaccordance with the present disclosure, with the sealing member in aninverted condition;

FIG. 18A is a highly schematic cross-sectional view of an embodiment ofa prosthetic heart valve having a sealing member for fillingirregularities between the heart valve and the native valve annulus inaccordance with the present disclosure, having an expandable anchorportion, with the sealing member in an extended condition;

FIG. 18B is a highly schematic cross-sectional view of the prostheticheart valve of FIG. 18A, with the sealing member in an invertedcondition; and

FIG. 18C is a highly schematic side view in partial cross-sectionshowing the prosthetic heart valve of FIG. 18B in a deployed positionwithin the native aortic annulus and ascending aorta of a patient.

Various embodiments of the present disclosure will now be described withreference to the appended drawings. It is to be appreciated that thesedrawings depict only some embodiments of the disclosure and aretherefore not to be considered limiting of its scope.

DETAILED DESCRIPTION

With conventional self-expanding valves, clinical success of the valveis dependent on accurate deployment and anchoring. Inaccurate deploymentand anchoring of the valve increases risks, such as those associatedwith valve migration. Inaccurate deployment and anchoring may alsoresult in the leakage of blood between the implanted heart valve and thenative valve annulus, commonly referred to as perivalvular leakage (alsoknown as “paravalvular leakage”). In aortic valves, this leakage enablesblood to flow from the aorta back into the left ventricle, reducingcardiac efficiency and putting a greater strain on the heart muscle.Additionally, calcification of the aortic valve may affect performanceand the interaction between the implanted valve and the calcified tissueis believed to be relevant to leakage, as will be outlined below.

Moreover, anatomical variations from one patient to another may cause afully deployed heart valve to function improperly, requiring removal ofthe valve from the patient. Removing a fully deployed heart valveincreases the length of the deployment procedure as well as the risk ofinfection and/or damage to heart tissue. Thus, methods and devices aredesirable that reduce the need to remove a prosthetic heart valve from apatient. Methods and devices are also desirable that reduce thelikelihood of perivalvular leakage due to gaps between the implantedheart valve and patient tissue.

As used herein, the term “proximal,” when used in connection with aprosthetic heart valve, refers to the end of the heart valve closest tothe heart when the heart valve is implanted in a patient, whereas theterm “distal,” when used in connection with a prosthetic heart valve,refers to the end of the heart valve farthest from the heart when theheart valve is implanted in a patient. When used in connection withdevices for delivering a prosthetic heart valve or other medical deviceinto a patient, the terms “proximal” and “distal” are to be taken asrelative to the user of the delivery devices. “Proximal” is to beunderstood as relatively close to the user, and “distal” is to beunderstood as relatively farther away from the user. Also as usedherein, the terms “generally,” “substantially,” “approximately,” and“about” are intended to mean that slight deviations from absolute areincluded within the scope of the term so modified.

When used to indicate relative locations within the aortic annulus, theaortic root, and the ascending aorta of a patient, the terms “above” and“below” are to be taken as relative to the juncture between the aorticannulus and the left ventricle. “Above” is to be understood asrelatively farther from the left ventricle, and “below” is to beunderstood as relatively closer to the left ventricle.

When used to indicate relative locations within the prosthetic heartvalve, the terms “longitudinal” and “vertical” are to be taken as thedirection of the axis extending between the proximal end and the distalend of the heart valve, along the direction of intended blood flow; theterm “flow direction” is to be taken as the direction from the proximalend to the distal end of the heart valve, along the direction ofintended blood flow; and the terms “above,” “below,” “high,” and “low”are to be taken as relative to the proximal end of the prosthetic heartvalve. “Above” and “high” are to be understood as relatively fartherfrom the proximal end of the heart valve in the direction of intendedblood flow, and “below” and “low” are to be understood as relativelycloser to the proximal end of the stent in the direction of intendedblood flow. When used to indicate relative locations within theprosthetic heart valve, the term “circumferential” is to be taken as thedirection of rotation about the longitudinal axis of the stent.

The sealing portions of the present disclosure may be used in connectionwith collapsible prosthetic heart valves. FIG. 1 shows one suchcollapsible stent-supported prosthetic heart valve 100 including stent102 and valve assembly 104 as is known in the art. The prosthetic heartvalve 100 is designed to replace a native tricuspid valve of a patient,such as a native aortic valve. It should be noted that while theembodiments herein are described predominantly in connection with theiruse with a prosthetic aortic valve and a stent having a shape asillustrated in FIG. 1, the valve could be a bicuspid valve, such as themitral valve, and the stent could have different shapes, such as aflared or conical annulus section, a less-bulbous aortic section, andthe like, and a differently shaped transition section.

Stent 102 may be formed from biocompatible materials that are capable ofself-expansion, such as, for example, shape memory alloys, such as thenickel-titanium alloy known as “Nitinol” or other suitable metals orpolymers. Stent 102 extends from proximal or annulus end 130 to distalor aortic end 132, and includes annulus section 140 adjacent proximalend 130, transition section 141, and aortic section 142 adjacent distalend 132. Annulus section 140 has a relatively small cross-section in theexpanded condition, while aortic section 142 has a relatively largecross-section in the expanded condition. Annulus section 140 may be inthe form of a cylinder having a substantially constant diameter alongits length. Transition section 141 may taper outwardly from annulussection 140 to aortic section 142.

Each of the sections of stent 102 includes a plurality of struts 160forming cells 162 connected to one another in one or more annular rowsaround the stent. For example, as shown in FIG. 1, annulus section 140may have two annular rows of complete cells 162 and aortic section 142and transition section 141 may each have one or more annular rows ofpartial cells 162. Cells 162 in aortic section 142 may be larger thancells 162 in annulus section 140. The larger cells in aortic section 142better enable prosthetic valve 100 to be positioned in the native valveannulus without the stent structure interfering with blood flow to thecoronary arteries.

Stent 102 may include one or more retaining elements 168 at distal end132 thereof, retaining elements 168 being sized and shaped to cooperatewith female retaining structures (not shown) provided on the deploymentdevice. The engagement of retaining elements 168 with the femaleretaining structures on the deployment device helps maintain prostheticheart valve 100 in assembled relationship with the deployment device,minimizes longitudinal movement of the prosthetic heart valve relativeto the deployment device during unsheathing or resheathing procedures,and helps prevent rotation of the prosthetic heart valve relative to thedeployment device as the deployment device is advanced to the targetlocation and the heart valve deployed.

Prosthetic heart valve 100 includes valve assembly 104, preferablypositioned in annulus section 140 of stent 102 and secured to the stent.Valve assembly 104 includes cuff 176 and a plurality of leaflets 178that collectively function as a one-way valve by coapting with oneanother. As a prosthetic aortic valve, prosthetic heart valve 100 hasthree leaflets 178. However, it will be appreciated that otherprosthetic heart valves with which the sealing portions of the presentdisclosure may be used may have a greater or lesser number of leaflets178.

Although cuff 176 is shown in FIG. 1 as being disposed on the luminal orinner surface of annulus section 140, it is contemplated that cuff 176may be disposed on the abluminal or outer surface of annulus section 140or may cover all or part of either or both of the luminal and abluminalsurfaces. Both cuff 176 and leaflets 178 may be wholly or partly formedof any suitable biological material or polymer such as, for example,polytetrafluoroethylene (PTFE), polyvinyl alcohol (PVA), ultra-highmolecular weight polyethylene (UHMWPE), silicone, urethane, and thelike.

Leaflets 178 may be attached along their belly portions to cells 162 ofstent 102, with the commissure between adjacent leaflets 178 attached tocommissure features 166. As can be seen in FIG. 1, each commissurefeature 166 may lie at the intersection of four cells 162, two of thecells being adjacent one another in the same annular row, and the othertwo cells being in different annular rows and lying in end-to-endrelationship. Preferably, commissure features 166 are positionedentirely within annulus section 140 or at the juncture of annulussection 140 and transition section 141. Commissure features 166 mayinclude one or more eyelets that facilitate the suturing of the leafletcommissure to stent 102.

Prosthetic heart valve 100 may be used to replace a native aortic valve,a surgical heart valve, a heart valve that has undergone a surgicalprocedure, or any other valve that is desired to be replaced. Prostheticheart valve 100 may be delivered to the desired site (e.g., near orproximate a native annulus, near or proximate an annuloplasty ring orother repair device) using any suitable delivery device.

During delivery, prosthetic heart valve 100 is disposed inside thedelivery device in the collapsed condition. The delivery device may beintroduced into a patient using a transfemoral, transapical,transseptal, transradial, transsubclavian, transaortic or any otherpercutaneous approach. Once the delivery device has reached the targetsite, the user may deploy prosthetic heart valve 100. Upon deployment,prosthetic heart valve 100 expands so that annulus section 140 is insecure engagement within the native annulus (or in engagement with anannuloplasty ring or other repair device). When prosthetic heart valve100 is properly positioned, it works as a one-way valve, allowing bloodto flow in an antegrade or flow direction, and preventing blood fromflowing in the opposite direction.

Problems may be encountered when implanting prosthetic heart valve 100.For example, in certain procedures, collapsible valves may be implantedin a native valve annulus without first resecting the native valveleaflets. The collapsible valves may have clinical issues because of thenature of the stenotic leaflets that are left in place. Additionally,patients with uneven calcification, bi-cuspid aortic valve disease,and/or valve insufficiency cannot be treated well, if at all, with thecurrent collapsible valve designs.

The reliance on unevenly-calcified leaflets for proper valve placementand seating could lead to several problems, such as perivalvular leakage(“PV leak”), which can have adverse clinical outcomes. To reduce theseadverse events, the optimal valve would anchor adequately and sealwithout the need for excessive radial force that could harm nearbyanatomy and physiology.

PV leak may also be caused by the implantation of a valve having anexpanded diameter that is too small relative to the native aorticannulus diameter, a prosthetic valve that is deployed in a tiltedorientation relative to the native aortic annulus (such that thelongitudinal axis of the valve and the native aortic annulus aremisaligned), lack of full radial expansion of the valve due to the stentcatching on calcific nodules in the native aortic annulus, and placingthe valve at a non-optimal longitudinal position relative to the nativeaortic annulus (either too high or too low along the central axis of thenative aortic annulus).

FIG. 2A is a highly schematic cross-sectional illustration of prostheticheart valve 100 disposed within native valve annulus 250A. As seen inthe figure, valve assembly 104 has a substantially circularcross-section which is disposed within the non-circular native valveannulus 250A. At certain locations around the perimeter of heart valve100, gaps 200A form between heart valve 100 and native valve annulus250A. Blood flowing through these gaps and past valve assembly 104 ofprosthetic heart valve 100 can cause regurgitation and otherinefficiencies which reduce cardiac performance. Such improper fitmentmay be due to suboptimal native valve annulus geometry due, for example,to calcification of native valve annulus 250A or to unresected nativeleaflets.

FIG. 2B is a similar cross-sectional illustration of prosthetic mitralvalve 100B disposed within native valve annulus 250B. As seen in thefigure, valve assembly 104B has a substantially D-shaped cross-sectionthat is disposed within irregularly-shaped annulus 250B. At certainlocations around the perimeter of heart valve 100B, gaps 200B formbetween heart valve 100B and native valve annulus 250B. Regurgitationand other inefficiencies may thus result after deployment of aprosthetic mitral valve. Though the following examples show aorticvalves, it will be understood that the present devices and methods maybe equally applicable to mitral and other heart valves.

FIGS. 3A-3C illustrate prosthetic heart valve 300 in accordance with anembodiment of the disclosure. As can be seen in FIG. 3A, prostheticheart valve 300 extends between proximal end 302 and distal end 304, andmay generally include stent 306 formed of a plurality of struts 307, andvalve assembly 308 having a plurality of leaflets 310 and cuff 312.

Valve assembly 308 includes a generally cylindrical sealing member 322that extends proximally from proximal end 313 of cuff 312. The sealingmember 322 may have smooth surfaces, rough or textured surfaces, or acombination of smooth surfaces with a rough or textured surface on oneor more surfaces or surface portions to promote tissue ingrowth, whichmay improve sealing between the sealing member and the native patientanatomy. In FIG. 3A, sealing member 322 is shown in an extendedcondition. In some examples, sealing member 322 in its extendedcondition may extend between about 8 mm and about 16 mm proximally ofproximal end 302 of stent 306 to free edge 323.

One or more removable sutures 330 may extend through respectiveapertures in sealing member 322 adjacent its free edge 323, and the freeends of each suture may extend proximally through a delivery device soas to be accessible to a user. In one example, one or more sutures 330may be pulled by the user at the proximal end of the delivery device tomove sealing member 322 from the extended condition (FIG. 3A) to aninverted condition (FIG. 3B), as will be described in greater detailbelow with reference to FIGS. 4E and 4F. In a variation, sutures 330 maybe replaced with other filamentary elements that may extend between freeedge 323 and the proximal end of the delivery device, such as at leastone polymer wire, braided metal wire, Nitinol wire, cord, ribbon, or anyother connecting member that may be used to pull sealing member 322 toan inverted condition (FIGS. 3B and 3C). In another variation (e.g.,FIGS. 10A-10C), one or more sutures 330 or other members may be pulledautomatically during deployment of prosthetic heart valve 300 from adelivery device. A description of this variation is set forth in detailbelow.

In FIGS. 3B and 3C, sealing member 322 is shown in the invertedcondition in which the sealing member may be annularly disposed aroundthe abluminal surface of cuff 312 at proximal end 302 of stent 306, suchthat a surface 324 of the sealing member that was facing radiallyoutward from the longitudinal axis of stent 306 in FIG. 3A confronts theabluminal surface of the cuff. In other words, sealing member 322 isinverted and folded proximally over proximal end 302 of stent 306.Proximal end 313 of cuff 312 where the cuff and sealing member 322 meetis disposed at the proximalmost junctions 309 a of the stent, and freeedge 323 of sealing member 322 is disposed at or near upper junctions309 b of the proximalmost struts 307 of stent 306.

In the inverted condition, sealing member 322 may have a radius largerthan that of the proximal end 302 of stent 306, the larger radius of thesealing member being capable of filling gaps between prosthetic heartvalve 300 and the native valve annulus and/or blocking blood flowthrough same.

To improve the capability of sealing member 322 to fill gaps betweenprosthetic heart valve 300 and the native valve annulus, sealing member322, and all of the other sealing members and rings described herein,may have an outward spring bias. Such an outward spring bias ispreferably small enough that the sealing member may expand to differentradial distances at some locations along the circumference of thesealing member than at other locations. The sealing member may expand agreater radial distance where there is minimal radial force applied tothe sealing member from the native anatomy (i.e., at locations at whichvoids or gaps between stent 306 and the native anatomy are present, suchas gaps 200A shown in FIG. 2A). The sealing member may expand a lesserradial distance where there is greater radial force applied to thesealing member from the native anatomy (i.e., at locations at whichthere are no such voids or gaps).

Sealing member 322 may be formed of the same material as cuff 312 andmay be formed integrally therewith from a single piece of material.Alternatively, sealing member 322 may be formed of the same material ora different material than cuff 312 that is sutured, glued or otherwiseaffixed to proximal end 313 of the cuff. In one example, sealing member322 may be made of a thin tubular fabric material. In other examples,sealing member 322 may include thin porcine pericardial tissue betweenabout 0.005 inches (127 μm) and about 0.007 inches (177.8 μm) inthickness, or ultra-high-molecular-weight polyethylene (UHMWPE) orpolyethylene terephthalate (PET) fabric between about 0.003 inches (76.2μm) and about 0.005 inches (127 μm) in thickness.

Alternatively, a variety of other materials may be used, includingbovine tissue (e.g., glycerol impregnated or freeze dried), tissue withsupport structures therein, wire mesh, radiopaque wire, fabric, braidedor woven fabric (e.g., polytetrafluoroethylene (PTFE), PET, or UHMWPE),fabric coated with PTFE or collagen, or a multi-layered composite of oneor more of the aforementioned materials (e.g., a fabric and tissuecomposite). Any of the sealing rings or sealing members disclosed hereinmay be made of any one of the aforementioned materials or a combinationthereof.

Sealing member 322 may be at least partially radiopaque, i.e., thesealing member may include one or more materials having enhancedvisibility to a user under fluoroscopy. For example, sealing member 322may be a fabric or wire mesh material having radiopaque fibers or may becomprised entirely of radiopaque fibers. Sealing member 322 may includeradiopaque marker beads, a thin radiopaque wire, radiopaque paint, ormay be impregnated with a radiopaque material such as silver, iodine,barium, platinum, or the like, such as by soaking the sealing member ina liquid including one or more of these chemicals. Any of the sealingmembers or sealing rings disclosed herein may include any one of theaforementioned radiopaque materials or a combination thereof.

Although the sutures 330 are described herein as extending throughapertures in sealing member 322 adjacent its free edge 323, theapertures need not be formed in the sealing member before the suturesare attached to the sealing member. The invention contemplates threadingthe sutures 330 directly through the material of sealing member 322. Forexample, in an embodiment in which sealing member 322 is made of afabric, sutures 330 may be threaded through gaps extending betweenfibers of the fabric, such that no additional apertures are created bythe action of threading the sutures through the sealing member.

A method of inverting sealing member 322 during release of prostheticheart valve 300 from distal sheath 342 of delivery device 340 (FIG. 4A)will now be described. Referring to FIG. 4A, prosthetic heart valve 300is disposed in a compartment defined within distal sheath 342 ofdelivery device 340, with the proximal end of the stent disposedadjacent distal tip 344 of the delivery device. In FIG. 4A, thecompartment is slightly open, with distal end 343 of distal sheath 342slightly spaced apart from distal tip 344 in the longitudinal directionL of delivery device 340. As shown in FIG. 4B, distal sheath 342 hasbeen withdrawn proximally in the longitudinal direction L, so that moreof sealing member 322 has been uncovered and protrudes radially awayfrom the longitudinal axis of delivery device 340.

FIGS. 4C and 4D show distal sheath 342 withdrawn further in the proximaldirection from distal tip 344, so that the entire sealing member 322 hasbeen uncovered and protrudes further radially away from the longitudinalaxis of delivery device 340. Removable sutures 330 can be seen in FIG.4D extending out of distal sheath 342 and through sealing member 322 ata location adjacent free edge 323.

FIG. 4E shows sealing member 322 being partially inverted relative tothe extended condition shown in FIG. 4D. A user may begin to invertsealing member 322 by pulling on sutures 330 in the longitudinaldirection L toward a proximal end (not shown) of delivery device 340.Sutures 330 may extend from a location adjacent free edge 323 of sealingmember 322 to the proximal end of delivery device 340 through acontainment tube (not shown) extending within distal sheath 342.

As can be seen in FIG. 4F, distal sheath 342 has been further withdrawnfrom the compartment, and sealing member 322 has been moved into theinverted condition. The proximal end 302 of stent 306 has been radiallyexpanded, thereby tightening sealing member 322 against the stent andcompleting the inversion of the sealing member. After sealing member 322has been inverted, a user may cut sutures 330 at the proximal end ofdelivery device 340, and may pull one end of each suture until thesuture withdraws from the apertures in sealing member 322 and from thedelivery device.

In one example, in an embodiment in which sutures 330 are pulledautomatically during deployment of prosthetic heart valve 300 from adelivery device, the sutures may remain in a patient with the cuffinstead of being removed, which may help sealing member 322 maintain aninverted position under backpressure from blood flowing through theprosthetic heart valve. The backpressure may help pin sealing member 322between stent 306 and the native anatomy of the patient, therebyanchoring the sealing member in place. In such an example, the suturesmay be biodegradable.

Instead of a user cutting sutures 330, the sutures may be released by adelivery device after sealing member 322 has been inverted. In aparticular example, the delivery device may include a cutting mechanismthat may be actuated by a user after sealing member 322 has beeninverted to cut sutures 330 that may be removed from a patient alongwith the delivery device.

In another embodiment, sutures 330 may extend between sealing member 322and a portion of a delivery device that may initially retain and laterrelease the sutures from the delivery device. For example, such aportion may include a clip having an initial closed condition in whichends of sutures 330 are retained therein, and after sealing member 322has been inverted, the clip may be opened by user actuation to releasethe sutures. In another example, such a portion may include a nitinolwire having an end extending out of a containment tube, the end of thewire having an initial hook-shaped condition (due to shape memory of thewire) in which ends of sutures 330 are retained thereon. After sealingmember 322 has been inverted, the end of the wire may be retracted intothe containment tube by user actuation to release the sutures. In suchembodiments, at least a portion of sutures 330 may be left in thepatient with the prosthetic heart valve 300, and such a portion of thesutures may be biodegradable.

As shown in FIGS. 4A-4F, sealing member 322 is inverted before proximalend 302 of stent 306 has fully radially expanded. However, that need notbe the case. In an alternative method of deployment, sealing member 322may be inverted after proximal end 302 of stent 306 has fully radiallyexpanded.

Other than sealing member 322 described above, all of the sealingmembers and sealing rings described herein have structures that mayprovide different surface areas and thicknesses of material at differentlongitudinal and circumferential positions relative to the stent toprovide different advantages in sealing voids or gaps between the stentand the native anatomy when the heart valves are deployed into apatient. Such differences in surface areas and thicknesses of materialat certain longitudinal and circumferential positions may make somesealing ring configurations preferable for certain native anatomies andother sealing ring configurations preferable for other native anatomies,depending on the anticipated locations of voids or gaps between adeployed prosthetic heart valve and the native anatomy. Such anticipatedlocations of voids or gaps between a deployed prosthetic heart valve andthe native anatomy may be determined by a variety of methods, includingimaging of the native anatomy before deployment of a prosthetic heartvalve, for example.

FIGS. 5A and 5B illustrate heart valve 300 a, which is the same as heartvalve 300 of FIGS. 3A-3C, except that heart valve 300 a includes agenerally toroidal-shaped sealing ring 325 disposed adjacent free edge323 of sealing member 322 a, which may permit prosthetic heart valve 300a to achieve improved sealing against the native annulus and the nativeleaflets in some patients.

FIG. 5A shows the inverted condition of sealing member 322 a, withsealing ring 325 attached to the sealing member at or near free edge323. Sealing ring 325 may be annularly disposed around the abluminalsurface of stent 306 above proximal end 302 of the prosthetic heartvalve (e.g., at a position that will lie within the native valve annuluswhen the prosthetic heart valve is deployed into a patient). Sealingring 325 may have a radius larger than that of valve assembly 308 a, thelarger radius of the sealing ring being capable of filling and/orblocking blood flow through gaps between prosthetic heart valve 300 aand the native valve annulus.

Sealing ring 325 may be formed of the same material as both sealingmember 322 a and cuff 312 and may be formed integrally with both ofthese members from a single piece of material. In such an embodiment,sealing ring 325 may be a rolled end portion of sealing member 322 a.Cuff 312, sealing member 322 a, and sealing ring 325 may be made of anyone or more of the materials described above with respect to sealingring 322, such as, for example, a thin fabric material, thin porcinepericardial tissue, bovine tissue, tissue with support structurestherein, braided or woven fabric, fabric coated with PTFE or collagen,or a multi-layered composite of one or more of the aforementionedmaterials.

Alternatively, sealing ring 325 may be formed of the same material or adifferent material than sealing member 322 a that is sutured, glued orotherwise affixed to sealing member 322 a adjacent free edge 323. Insuch an embodiment, sealing ring 325 may be formed, for example, from along, thin rectangle of material about 10 mm in width that is foldedapproximately in half longitudinally, and the opposed longitudinal edgesmay be stitched to one another to create a flattened tube about 4 mm indiameter. In other examples, such a flattened tube may be between about2 mm and about 6 mm in diameter. The lateral ends of the flattened tubemay be stitched to one another to create sealing ring 325.

As can be seen in FIG. 5B, when sealing member 322 a is in the extendedcondition, sealing ring 325 is disposed on a surface 326 facing radiallyinward toward the longitudinal axis of stent 306. When sealing member322 a is moved to the inverted condition shown in FIG. 5A, using themethod shown in FIGS. 4A-4F for example, surface 326 of the sealingmember will face radially outward away from the longitudinal axis ofstent 306, and sealing ring 325 will face radially outward as well. Whensealing member 322 a is in the extended condition (FIG. 5B), its typicalcondition when positioned within a delivery device, the entirety ofsealing ring 325 lies below proximalmost junctions 309 a of stent 306,enabling a smaller crimped profile to be achieved compared to when thesealing member is in the inverted condition (FIG. 5A).

Although sealing ring 325 is shown in FIGS. 5A and 5B as having acircular cross-section, that need not be the case. Sealing ring 325 maybe flattened in the flow direction, or it may have a cross-section thatis square, rectangular, triangular, or other shapes. It is to beunderstood that all of the “sealing rings” described herein are not tobe understood to be limited to having a circular cross-section. Any ofthe sealing rings described herein may be flattened in the flowdirection, or they may have a cross-section that is square, rectangular,triangular, or other shapes.

FIG. 5C illustrates heart valve 300 b, which is the same as heart valve300 a of FIGS. 5A and 5B, except that heart valve 300 b includes asecond sealing ring 327 disposed adjacent sealing ring 325. The presenceof second sealing ring 327 along with sealing ring 325 may permitprosthetic heart valve 300 b to achieve improved sealing against thenative annulus and the native leaflets in some patients.

When sealing member 322 a is in the inverted condition shown in FIG. 5C,second sealing ring 327 is disposed proximally of sealing ring 325,between sealing ring 325 and proximalmost junctions 309 a of stent 306,facing radially outward away from the longitudinal axis of the stent.When sealing member 322 a is in the extended condition (not shown),second sealing ring 327 is disposed distally of sealing ring 325 onsurface 326, facing radially inward toward the longitudinal axis ofstent 306.

In one example (not shown), second sealing ring 327 may be spaced apartfrom sealing ring 325 and positioned adjacent proximal end 302 of stent306 when sealing member 322 a is in the inverted condition (e.g., at aposition that will lie at least partially below the native valve annuluswhen the prosthetic heart valve is deployed into a patient). AlthoughFIG. 5C shows sealing member 322 a with two sealing rings, the sealingmember may include more than two sealing rings arranged sequentiallyalong the sealing member.

Second sealing ring 327 may be formed of the same material as sealingmember 322 a, and/or cuff 312, and/or sealing ring 325, and may beformed integrally with one or more of these members from a single pieceof material. Alternatively, second sealing ring 327 may be formed of thesame material or a different material than sealing member 322 a, and/orcuff 312, and/or sealing ring 325 that is sutured, glued or otherwiseaffixed to sealing member 322 a adjacent sealing ring 325. In such anembodiment, second sealing ring 327 may be formed, for example, from along, thin rectangle of material about 10 mm in width that is foldedapproximately in half longitudinally, and the opposed longitudinal edgesmay be stitched to one another to create a flattened tube about 4 mm indiameter. The lateral ends of the flattened tube may be stitched to oneanother to create second sealing ring 327.

When sealing member 322 b is in the extended condition (not shown), itstypical condition when positioned within a delivery device, the entiretyof both sealing ring 325 and sealing ring 327 lies below proximalmostjunctions 309 a of stent 306, enabling a smaller crimped profile to beachieved compared to when the sealing member is in the invertedcondition (FIG. 5C). Although sealing rings 325 and 327 of prostheticheart valve 300 b are shown in FIG. 5C as having an identical structure,that need not be the case. In other embodiments, the two sealing ringsmay have structures that are different from one another, such as acombination of a flat toroidal sealing ring and a zig-zag sealing ring,such as sealing ring 525 e shown in FIG. 5E and described below.

FIGS. 5D-5G illustrate variants of sealing rings that may be used withprosthetic heart valves 300 a or 300 b in addition to or in place of thesealing rings shown in FIGS. 5A-5C. Each of sealing rings 525 d-525 gshown in FIGS. 5D-5G may be formed in the same manner, attached to thesealing member in the same manner, and made of the same material ormaterials described above with reference to sealing rings 325 and 327.Each of the sealing rings 525 d-525 g may be attached to a sealingmember in any location along the longitudinal axis of the sealingmember. A prosthetic heart valve, such as prosthetic heart valve 300 a,may include one of sealing rings 525 d-525 g, or alternatively, theprosthetic heart valve may include two or more of the sealing rings, asshown in FIG. 5C.

FIG. 5D shows sealing ring 525 d in the shape of a bent or saddle-shapedtoroid that alternates between peaks 560 d and valleys 570 d around thecircumference of the sealing ring, the peaks and valleys beingsubstantially evenly distributed about the circumference. As shown inFIG. 5D, sealing ring 525 d may have two peaks 560 d and two valleys 570d, but may have other numbers of peaks and valleys, such as three, forexample, as will be described below with reference to FIGS. 6A and 6B.

FIG. 5E shows sealing ring 525 e having a zig-zag shape that alternatesbetween peaks 560 e and valleys 570 e around the circumference of thesealing ring, the peaks and valleys being substantially evenlydistributed about the circumference. As shown in FIG. 5E, sealing ring525 e may have nine peaks 560 e and nine valleys 570 e, but may haveother numbers of peaks and valleys, such as three or six, for example. Asealing ring having a zig-zag shape may be stitched or otherwiseattached to a cuff such that the sealing ring will generally follow thecontour of the struts when the cuff is moved to an inverted conditionsuch as that shown in FIG. 5A. However, in other embodiments, sealingring 525 e may be attached to the cuff at other locations.

FIG. 5F shows sealing ring 525 f having a zig-zag shape with alternatingpeak heights. Sealing ring 525 f alternates between peaks 560 f andvalleys 570 f around the circumference of the sealing ring, the peaksand valleys being substantially evenly distributed about thecircumference. As shown in FIG. 5F, sealing ring 525 f may have ninepeaks 560 f and nine valleys 570 f, but may have other numbers of peaksand valleys, such as three or six, for example.

Peaks 560 f include low peaks 561 that extend by a first height H1 abovevalleys 570 f and high peaks 562 that extend by a second height H2 abovethe valleys, the second height being greater than the first height. Asshown in FIG. 5F, peaks 560 f may include four low peaks 561 and fourhigh peaks 562, with one low peak separating adjacent ones of the highpeaks. In other embodiments, there may be other numbers of high and lowpeaks. For example, a sealing ring having varying peak heights mayinclude six low peaks and three high peaks, with two low peaksseparating adjacent ones of the high peaks. In another example, asealing ring having varying peak heights may include three low peaks andsix high peaks, with two high peaks separating adjacent ones of the lowpeaks.

FIG. 5G shows sealing ring 525 g having a toroidal shape, similar to thetoroidal-shaped sealing ring 325 shown in FIGS. 5A and 5B. Sealing ring525 g has openings 563 in a top surface 564 thereof. Openings 563 may beround holes or may be holes having any other shapes or slits having anyshape. Sealing ring 525 g may be attached to a cuff of a prostheticheart valve in a similar manner as that described above with referenceto sealing ring 325 shown in FIGS. 5A and 5B.

When sealing ring 525 g is attached to a cuff of a prosthetic heartvalve, openings 563 and top surface 564 will preferably face toward thedistal end of the stent. When deployed in a patient, openings 563 mayallow sealing ring 525 g to fill with blood, which may augment theability of the sealing ring to seal against the native aortic annulus orother native tissue structures. Instead of or in addition to openings563, sealing ring 525 g may include expanding materials within theinterior of the sealing ring, such as polyacrylimide or otherhydroscopic materials, PVA, shape memory foam, bovine gelatin orcollagen, or the like. As these materials come in contact with blood,they expand, again augmenting the ability of the sealing ring to sealagainst the native tissue.

FIG. 5H is a radial cross-section of sealing ring 525 h having featuresthat may be incorporated into any of the sealing rings described herein.Sealing ring 525 h may be formed in the same manner, attached to thecuff in the same manner, and made of the same material or materials asdescribed above with reference to sealing rings 325 and 327.

Top surface 564 of sealing ring 525 h may be made of a porous materialhaving many small openings 563 h that are adapted to allowunidirectional blood flow into interior 565 of the sealing ring. Sealingring 525 h may have a bottom surface 566 without openings, and thereforemay be substantially less permeable than top surface 564. Bottom surface566 may be made of a low-porosity material such as a tightly-wovenfabric that may have a collagen or PVA coating, for example. Sealingring 525 h may be coated on the exterior of top surface 564 and/orbottom surface 566 with a material (e.g., Ag or a drug compound) toprevent a thrombus or infection from forming thereon. Blood that flowsinto interior 565 of sealing ring 525 h may coagulate and/or in-growinto the material of sealing ring 525 h, which may help providestiffness to the sealing ring in a radial direction.

FIGS. 6A-6F illustrate prosthetic heart valve configurations that haveembodiments of sealing rings that are variants of sealing ring 325 shownin FIGS. 5A and 5B, which sealing ring embodiments include stored energyelements in the form of springs that are configured to force portions ofthe outer edge of the sealing ring away from the cuff in locations atwhich voids or gaps between the stent and the native anatomy arepresent.

Each of sealing rings 625 a-625 f shown in FIGS. 6A-6F may be formed inthe same manner, attached to sealing member 622 in the same manner,moved to the inverted condition along with the sealing member in thesame manner, and made of the same material or materials described abovewith reference to sealing ring 325, with the exception of the additionof a stored energy element. Sealing rings 625 a and 625 c-625 f may eachbe attached to sealing member 622 in any position along the length ofthe sealing member. A prosthetic heart valve, such as prosthetic heartvalve 600, may include one of sealing rings 625 a or 625 c-625 f, oralternatively, two or more of the sealing rings. Each of sealing rings625 a and 625 c-625 f may be used to replace or to supplement sealingrings 325 and/or 327 in prosthetic heart valve 300 a or 300 b.

FIGS. 6A and 6B show sealing ring 625 a in the shape of a bent orsaddle-shaped toroid similar to sealing ring 525 d shown in FIG. 5D,except that sealing ring 625 a has three peaks 660 a and three valleys670 a substantially evenly distributed about the circumference of thesealing ring. Sealing ring 625 a has a stored energy element in the formof coiled spring 680 a that extends continuously through the interior ofthe sealing ring or through substantial portions of the sealing ring.

At least partially due to the capability of spring 680 a to storeenergy, sealing ring 625 a (and the other sealing rings disclosed hereinthat incorporate spring elements) may have a spring bias that provides aforce in a radially outward direction when the sealing ring is radiallycompressed. To provide this spring bias, each spring 680 a (and theother spring elements in the sealing rings disclosed herein) may be madefrom a material having a shape memory, such as nitinol wire or springsteel.

When prosthetic heart valve 600 is radially compressed inside a deliverydevice, spring 680 a will be under radial compression against its bias.When prosthetic valve 600 is initially released from the delivery devicewith sealing member 622 in the extended condition (not shown), sealingring 625 a will be facing radially inward from the surface of thesealing member, and spring 680 a will radially expand according to thebias of the spring. When sealing member 622 is moved to the invertedcondition shown in FIG. 6A, sealing ring 625 a will be facing radiallyoutward from the surface of the sealing member, and spring 680 a willfurther radially expand so that outer edge 628 of sealing ring 625 awill move radially outward from inner edge 629.

As shown in FIG. 6C, sealing ring 625 c has a plurality of stored energyelements in the form of springs 680 c circumferentially spaced apartfrom one another about the interior of the sealing ring. Each spring 680c has a first end 681 located at inner edge 629 of sealing ring 625 cand a second end 682 located at outer edge 628. Each spring 680 cpreferably extends away from inner edge 629 in a direction substantiallyperpendicular to the flow direction through the stent to which sealingring 625 c is attached. When a sealing member having sealing ring 625 cattached thereto is moved to an inverted condition such as that shown inFIG. 6A, second end 682 of each spring 680 c preferably moves radiallyoutward from inner edge 629 according to its bias, thereby pushing outeredge 628 of the sealing ring away from the inner edge. The springs 680 cmay each be flat leaf springs, or they may be portions of coil springsin the form of a spiral or a circular hoop. In embodiments where thesprings 680 c are in the form of a spiral or circular hoop, first end681 and second end 682 of each spring are understood to be the portionsof the spiral or circular hoop closest to inner edge 629 and outer edge628, respectively.

FIG. 6D shows sealing ring 625 d that is the same as sealing ring 625 cof FIG. 6C, except that each spring 680 d is oriented at an acute anglewith respect to the circumference of the stent. When viewed from a topsurface of sealing ring 625 d, as shown in FIG. 6D, springs 680 d may beoriented in a clockwise direction about the longitudinal axis of thesealing ring from their first ends 681 to their second ends 682.Alternatively, springs 680 d may be oriented in a counterclockwisedirection about the longitudinal axis of the sealing ring from theirfirst ends 681 to their second ends 682. The springs 680 d may each beflat leaf springs, or they may be portions of coil springs in the formof a spiral or a circular hoop. In embodiments where the springs 680 dare in the form of a spiral or circular hoop, first end 681 and secondend 682 of each spring are understood to be the portions of the spiralor circular hoop closest to inner edge 629 and outer edge 628,respectively.

FIG. 6E shows sealing ring 625 e that is the same as sealing ring 625 aof FIGS. 6A and 6B, except that the stored energy element is in the formof leaf spring 680 e that extends in at least one complete loop throughthe sealing ring, such that first end 681 and second end 682 of thespring overlap one another in the circumferential direction of thesealing ring. Similar to sealing ring 625 a, when a prosthetic valvehaving sealing ring 625 e is released from a delivery device and thesealing member is moved to the inverted condition shown in FIG. 6A,spring 680 e will radially expand, such that outer edge 628 of thesealing ring moves radially outward from inner edge 629 according to thebias of the spring.

FIG. 6F shows sealing ring 625 f that is the same as sealing ring 625 eof FIG. 6E, except that leaf spring 680 f includes ratchet element 683that slidably couples either first end 681 or second end 682 of thespring to another portion of the spring. Ratchet element 683 includesfirst and second portions that move past one another to allow the leafspring to radially expand, but that engage with one another to preventthe leaf spring from radially contracting. Similar to sealing ring 625e, when a prosthetic valve having sealing ring 625 f is released from adelivery device and the sealing member is moved to the invertedcondition shown in FIG. 6A, spring 680 f will radially expand, such thatouter edge 628 of the sealing ring moves radially outward from inneredge 629 according to the bias of the spring. Once spring 680 f hasexpanded, it will substantially maintain its diameter due to theengagement of the first and second portions of ratchet element 683,preventing the spring from re-collapsing to a smaller radial profile.

FIGS. 7A-7C illustrate prosthetic heart valve 700, which is the same asprosthetic heart valve 300 of FIGS. 3A-3C, except that prosthetic heartvalve 700 includes sealing member 722 that, rather than inverting, isconfigured to move from an extended condition shown in FIG. 7B to acompressed or bunched condition shown in FIGS. 7A and 7C which maypermit prosthetic heart valve 700 to achieve improved sealing againstthe native annulus and the native leaflets in some patients. In thecompressed condition, sealing member 722 may have a bunched shapesomewhat resembling the bunched shape of a roman shade, in which peaks726 droop to a position proximal of adjacent valleys 724.

As can be seen in FIG. 7A, prosthetic heart valve 700 extends betweenproximal end 702 and distal end 704, and may generally include stent 706formed of a plurality of struts 707, and valve assembly 708 having aplurality of leaflets and cuff 712.

Valve assembly 708 includes a generally smooth sealing member 722 thatextends from a proximal end 713 of cuff 712. Proximal end 721 of sealingmember 722 at which the cuff 712 and sealing member meet may be disposedat proximalmost junctions 709 a of stent 706. In one example (notshown), proximal end 721 of sealing member 722 may be attached to cuff712 and/or stent 706 between proximalmost junctions 709 a of stent 706and upper junctions 709 b of the proximalmost struts of the stent. Inother examples (not shown), proximal end 721 of sealing member 722 maybe attached to cuff 712 and/or stent 706 anywhere along annulus section740 of the stent, so that in the compressed condition, the sealingmember may cover a portion of or all of the annulus section of thestent.

Sealing member 722 may include valley portions 724 and peak portions 726that alternate in the longitudinal direction of stent 706. A pluralityof sutures 730 may extend through apertures 732 located within thevalley portions. Sealing member 722 may include at least two sutures730, or a multitude of sutures spaced around the circumference thereof.Sutures 730 may extend from a location adjacent free edge 723 of sealingmember 722 to the proximal end of a delivery device through acontainment tube (not shown) extending within a distal sheath of thedelivery device. When sealing member 722 is in the extended condition,shown in FIG. 7B, valley portions 724 and peak portions 726 may begenerally flattened, such that the peak portions extend radially outwardonly a small distance relative to the valley portions.

In some embodiments, when sealing member 722 is in the extendedcondition, the valley portions 724 and peak portions 726 may besubstantially completely flattened, so that the sealing member has ashape similar to the shape of sealing member 322 shown in FIG. 3A.

Removable sutures 730 may be pulled by a user to move sealing member 722from the extended condition (FIG. 7B) to the compressed condition (FIGS.7A and 7C). As the sutures are pulled by the user, free edge 723 ofsealing member 722 is moved toward proximal end 702 of stent 706. Asfree edge 723 moves distally, the material of sealing member 722 bucklesat the locations of valley portions 724 and peak portions 726, until thevalley portions are pulled to a position adjacent one another with thepeak portions extending radially outward therefrom. In the compressedcondition of sealing member 722 shown in FIG. 7C, each peak 726 maydroop below the adjacent proximal valley 724. In other words, each peak726 may have a central portion 726 a that extends proximally of therespective proximally adjacent valley 724 a.

In the extended condition of sealing member 722 shown in FIG. 7B, freeedge 723 may be located a first distance proximally of proximal end 702of stent 706, and in the compressed condition of the sealing membershown in FIGS. 7A and 7C, the free edge may be located a second distanceproximally of the proximal end of the stent, the first distance beinggreater than the second distance. Preferably, the first distance may beat least double the second distance. In other examples, the firstdistance may be at least triple the second distance, or the firstdistance may be at least quadruple the second distance.

Once sealing member 722 has been moved to the compressed condition, auser may cut sutures 730 at the proximal end of the delivery device, andmay pull one end of each suture until the suture withdraws fromapertures 732 in sealing member 722 and from the delivery device.

Similar to the alternative methods of deploying prosthetic heart valve300 a having sealing member 322 a shown in FIGS. 4A-4F, sealing member722 may be moved to the compressed condition either before proximal end702 of stent 706 has fully radially expanded, or after the proximal endof the stent has fully radially expanded.

FIGS. 7D and 7E illustrate sealing member 722 a that is a variant ofsealing member 722. In sealing member 722 a, apertures 732 through whichremovable sutures 730 extend are located between valleys 724 and peaks726 of the sealing member. As a result, when sealing member 722 a ismoved from the extended condition (FIG. 7D) to the compressed condition(FIG. 7E), the material of the sealing member buckles so that valleys724 are located radially inward from apertures 732, and peaks 726 arelocated radially outward from the apertures. In the compressed conditionshown in FIG. 7E, sealing member 722 a may have a bunched shape somewhatresembling the bunched shape of a cellular shade, in which peaks 726 andvalleys 724 may have a regular zig-zag pattern.

In the extended condition of sealing member 722 a shown in FIG. 7D, freeedge 723 may be located a first distance proximally of proximal end 702of stent 706, and in the compressed condition of the sealing membershown in FIG. 7E, the free edge may be located a second distanceproximally of the proximal end of the stent, the first distance beinggreater than the second distance. Preferably, the first distance may beat least double the second distance. In other examples, the firstdistance may be at least triple the second distance, or the firstdistance may be at least quadruple the second distance.

In a variant (not shown) of sealing members 722 and 722 a shown in FIGS.7A-7E, the sealing members may be made of a material, such as a nitinolsheet, that is configured to move to the compressed condition shown inFIG. 7A, 7C, or 7E when the material comes in contact with heat (e.g.,the heat from a patient's bloodstream). In such a variant, sutures 730may be omitted, because the sealing members can move from the extendedcondition to the compressed condition merely by retracting the distalsheath of the delivery device, without the need to pull on sutures.

In another variant (not shown) of sealing members 722 and 722 a shown inFIGS. 7A-7E, the sealing members may include one or more of any of thesealing rings shown and described above with reference to FIGS. 5Athrough 6F. Such sealing rings may extend circumferentially around anoutwardly-facing surface of the sealing members 722 or 722 a.

Although the sutures 730 of FIGS. 7A-7E are described herein asextending through apertures in sealing member 722 and sealing member 722a, the apertures need not be formed in the sealing member before thesutures are attached to the sealing member. The invention contemplatesthreading the sutures 730 directly through the material of sealingmember 722. For example, in an embodiment where sealing member 722 ismade of a fabric, sutures 730 may be threaded through gaps extendingbetween fibers of the fabric, such that no additional apertures arecreated by the action of threading the sutures through the sealingmember.

In a variation, sutures 730 of FIGS. 7A-7E may be replaced with otherfilamentary elements, such as at least one polymer wire, braided metalwire, Nitinol wire, cord, ribbon, or any other connecting member thatmay be used to pull sealing member 722 to a compressed condition (e.g.,FIG. 7A, 7C, 7E.)

In another variant (e.g., FIG. 8C), sutures 730 of FIGS. 7A-7E may bereplaced with elastomeric elements that may automatically (i.e., withoutactuation by the user independent from actuation of the distal sheath)move sealing member 722 from the extended condition to the compressedcondition during unsheathing of the valve. A description of thisvariation is set forth in detail below, with respect to FIG. 8C.

FIGS. 8A and 8B illustrate prosthetic heart valve 800, which is the sameas prosthetic heart valve 300 of FIGS. 3A-3C, except that rather thanhaving removable sutures 330, prosthetic heart valve 800 includesretractable filaments 830 that are configured to shorten without beingpulled by a user. Filaments 830 may extend along the outside surface ofsealing member 822 and cuff 812 at spaced positions around thecircumference of the sealing member from a proximal position 832 atwhich the filaments are attached at or adjacent free edge 823 of thesealing member to a position on stent 806. Although filaments 830 areshown in FIGS. 8A and 8B extending from proximal position 832 to distalposition 834 at or near distal end 804 of stent 806, that need not bethe case. Distal position 834 at which filaments 830 are attached tostent 806 may be any location along the stent that will be locateddistally of free edge 823 of sealing member 822 when the sealing membermoves to the inverted condition shown in FIG. 8B.

Filaments 830 may have an unstressed length and a shape memory suchthat, when a longitudinal force is applied to stretch the filaments toan extended length, the filaments have a spring bias that tends toshorten the filaments back to their unstressed length. Filaments 830 maybe made from elastic sutures, for example, and preferably are made of abiocompatible material so that they may be left in a patient after thedeployment of prosthetic heart valve 800.

When prosthetic heart valve 800 is radially compressed within distalsheath 842 of delivery device 840, sealing member 822 is radiallycompressed and held in the extended condition shown in FIG. 8A by africtional force acting between the distal sheath and the sealingmember. In this extended condition, filaments 830 are stretched to theirextended length so as to be under tension.

To move sealing member 822 from the extended condition to the invertedcondition shown in FIG. 8B, the user may retract distal sheath 842 offof proximal end 802 of stent 806, thereby removing the frictional forcekeeping the sealing member in the extended condition and filaments 830at their extended length. Once distal sheath 842 is retracted, thetension in filaments 830 will cause them to shorten, thereby pullingfree edge 823 of sealing member 822 in a distal direction and moving thesealing member to the inverted condition shown in FIG. 8B.

In an alternative embodiment, filaments 830 may be made from shrinkablenitinol, a shrinkable material that has a first extended length, andwhen the filaments are exposed to blood, the filaments shrink to asecond contracted length less than the first extended length. In such anembodiment, the filaments 830 will not be under tension. Instead, whendistal sheath 842 is retracted, filaments 830 will contact blood, andthe resulting rise in the temperature of the filaments will cause themto shorten, thereby pulling free edge 832 of sealing member 822 in adistal direction and moving the sealing member to the inverted conditionshown in FIG. 8B.

FIG. 8C illustrates prosthetic heart valve 800 a, which is the same asprosthetic heart valve 800, except that sealing member 822 a isconfigured to shorten to the compressed condition shown in FIGS. 7A-7E,rather than invert. When prosthetic heart valve 800 a is in an extendedcondition, it may look similar to the extended condition of prostheticheart valve 800 shown in FIG. 8A. However, once the distal sheath of thedelivery device is retracted off of proximal end 802 of stent 806,filaments 830 will shorten as described above, thereby pulling free edge823 of sealing member 822 a in a distal direction and moving the sealingmember to the compressed condition shown in FIG. 8C.

Although filaments 830 are shown in FIG. 8C extending from proximalposition 832 to distal position 834 at or near distal end 804 of stent806, that need not be the case. Distal position 834 at which filaments830 are attached to stent 806 may be any location along the stent thatwill be distal of free edge 823 of sealing member 822 a when the sealingmember moves to the compressed condition shown in FIG. 8C.

In an alternative embodiment (not shown), filaments 830 may be replacedwith an elastomeric strip (and/or another energy storage element)stitched into or otherwise attached to sealing member 822 a in atensioned state. In such an embodiment, the elastomeric strips will beunder tension when sealing member 822 a is in the extended condition.When sealing member 822 a of prosthetic heart valve 800 a is unsheathed,the elastomeric strips may automatically contract, thereby movingsealing member 822 a to the compressed condition.

FIGS. 9A and 9B illustrate prosthetic heart valve 900, which is the sameas prosthetic heart valve 800, except that sealing member 922 is biasedto move to a rolled condition to form sealing ring 925 as shown in FIG.9B, rather than to an inverted condition.

As can be seen in FIG. 9A, stent 906 may include a plurality ofindependent fingers 911 at spaced positions around the circumference ofsealing member 922, each finger extending proximally along sealingmember 922 to a free end 913 at least 8 mm from one of proximalmostjunctions 909 a of the stent. In other examples, each finger may extendproximally along sealing member 922 to a free end 913 at least mm fromthe proximalmost junction, or each finger may extend proximally alongthe sealing member to the free end at least 16 mm from the proximalmostjunction. Free ends 913 of fingers 911 may be attached to sealing member922 adjacent free edge 923 thereof. Fingers 911 may have a shape memorythat tends to roll the fingers into the spiral shape shown in FIG. 9Bwhen the fingers are not being forced into a substantially straightconfiguration.

When prosthetic heart valve 900 is radially compressed within the distalsheath of a delivery device, sealing member 922 is radially compressedand held in the extended condition shown in FIG. 9A by a frictionalforce acting between the distal sheath and the sealing member. In thisextended condition, fingers 911 are straightened against their bias.

To move sealing member 922 from the extended condition to the rolledcondition shown in FIG. 9B, the user may retract the distal sheath offof the proximal end 902 of stent 906, thereby removing the force that iskeeping the sealing member in the extended condition and fingers 911 intheir straight configuration. Once the distal sheath is retracted,fingers 911 will assume the rolled condition, thereby rolling sealingmember 922 outwardly in the direction of the distal end of stent 906 toform sealing ring 925 such that a distal surface 923 of the sealing ringis at substantially the same height as the proximalmost junctions 909 aof the stent.

As shown in FIG. 9B, sealing member 922 may be rolled into a generallytoroidal-shaped sealing ring 925 near proximal end 902 of stent 906(e.g., at a position that will lie at least partially below the nativevalve annulus when the prosthetic heart valve is deployed into apatient). Sealing ring 925 may be formed of one complete revolution ofsealing member 922, or of a series of revolutions (e.g., two, three ormore revolutions of the sealing member).

Referring now to FIGS. 10A and 10B, an exemplary transfemoral deliverydevice 10 for collapsible prosthetic heart valves of the types describedabove (or other types of implantable medical devices) has catheterassembly 16 for delivering the heart valve to and deploying the heartvalve at a target location, and operating handle 20 for controllingdeployment of the valve from the catheter assembly. Delivery device 10extends from proximal end 12 (FIG. 10B) to atraumatic tip 14 at thedistal end of catheter assembly 16. Catheter assembly 16 is adapted toreceive a collapsible prosthetic heart valve (e.g., prosthetic heartvalve 300 shown in FIGS. 3A-3C) in compartment 23 defined around innershaft 26 and covered by distal sheath 24.

Inner shaft 26 may extend through operating handle 20 and catheterassembly 16 to atraumatic tip 14 of the delivery device, and includesretainer 25 affixed thereto at a spaced distance from atraumatic tip 14and adapted to hold a collapsible prosthetic valve in compartment 23.Retainer 25 may have recesses 80 therein that are adapted to holdcorresponding retention members of the valve. Inner shaft 26 may be madeof a flexible material such as braided polyimide or polyetheretherketone(PEEK), for example. Using a material such as PEEK may improve theresistance of inner shaft 26 to kinking while catheter assembly 16 istracking through the vasculature of a patient.

Distal sheath 24 surrounds inner shaft 26 and is slidable relative tothe inner shaft such that it can selectively cover or uncovercompartment 23. Distal sheath 24 is affixed at its proximal end to outershaft 22, the proximal end of which is connected to operating handle 20in a manner to be described below. Distal end 27 of distal sheath 24abuts a proximally-facing abutment surface 15 of atraumatic tip 14 whenthe distal sheath is fully covering compartment 23, and is spaced apartfrom the proximally-facing abutment surface 15 when the compartment isat least partially uncovered.

Operating handle 20 is adapted to control deployment of a prostheticvalve located in compartment 23 by permitting a user to selectivelyslide outer shaft 22 proximally or distally relative to inner shaft 26,thereby respectively uncovering or covering the compartment with distalsheath 24. In some examples, operating handle 20 is configured torepeatedly cover or uncover the compartment with distal sheath 24. Forexample, compartment 23 may be uncovered to expose a valve and allow itto expand at a target location. Once at the location, the functionalityand positioning of the valve may be examined prior to complete releaseof the valve. If the functioning or position of the valve is improper,distal sheath 24 may be advanced to cover the compartment and the valvemay be redeployed in a different position or orientation.

Outer shaft 22 may be made of a flexible material such as nylon 11 ornylon 12, and may have a round braid construction (i.e., roundcross-section fibers braided together) or a flat braid construction(i.e., rectangular cross-section fibers braided together), for example.The proximal end of inner shaft 26 may be connected in a substantiallyfixed relationship to outer housing 30 of operating handle 20, and theproximal end of outer shaft 22 may be affixed to carriage assembly 40that is slidable along a longitudinal axis of the handle housing, suchthat a user can selectively slide the outer shaft relative to the innershaft by sliding the carriage assembly relative to the housing. Ahemostasis valve 28 may be provided and may include an internal gasketadapted to create a seal between inner shaft 26 and the proximal end ofouter shaft 22.

Handle housing 30 includes a top portion 30 a and a bottom portion 30 b.The top and bottom portions 30 a and 30 b may be individual piecesjoined to one another as shown in FIG. 10B. Collectively, top and bottomportions 30 a and 30 b define elongated space 34 in housing 30 in whichcarriage assembly 40 may travel. Elongated space 34 preferably permitscarriage assembly 40 to travel a distance that is at least as long asthe anticipated length of the prosthetic valve to be delivered (e.g., atleast about 20 mm, 45 mm, or 50 mm), such that distal sheath 24 can befully retracted from around the prosthetic valve. Carriage assembly 40has a body portion 41 with threaded rod 36 extending proximallytherefrom along the longitudinal axis of housing 30. Carriage assembly40 may further include a pair of carriage grips 42 each attached to bodyportion 41 by a respective carriage grip shaft (not shown).

Handle housing 30 further defines a pocket 37 that extends through topportion 30 a and bottom portion 30 b for receiving deployment actuator21. Deployment actuator 21 is internally threaded for selectiveengagement with threaded rod 36. When deployment actuator 21 is inthreaded engagement with threaded rod 36, rotation of the deploymentactuator in one direction (either clockwise or counterclockwisedepending on the orientation of the threads on the threaded rod) causesthe threaded rod to move proximally, at the same time pulling bodyportion 41 of carriage assembly 40 proximally through elongated space34, and pulling outer shaft 22 and distal sheath 24 proximally relativeto inner shaft 26. Similarly, when deployment actuator 21 is in threadedengagement with threaded rod 36, rotation of the deployment actuator inthe opposite direction causes the threaded rod to move distally throughelongated space 34, which pushes outer shaft 22 and distal sheath 24distally relative to inner shaft 26. When deployment actuator 21 isdisengaged from threaded rod 36, the threaded rod may be translatedwithout rotation of the deployment actuator by a user grasping andmoving carriage grips 42.

Handle 20 may also include a resheathing lock adapted to limit thelongitudinal movement of carriage assembly 40 proximally within handlehousing 30, thereby preventing the user from completing the deploymentof a prosthetic valve unintentionally. The initial distance thatcarriage assembly 40 can travel before being limited by the resheathinglock may be about 80% to about 90% of the length of an exemplary 50 mmvalve. Further details of the coupling assembly and embodiments ofresheathing locks suitable for use with delivery device 10 are shown anddescribed in co-pending and co-owned U.S. Patent Application PublicationNo. 2013/0297011, the disclosure of which is hereby incorporated byreference herein.

FIG. 10C shows prosthetic valve 300 of FIGS. 3A-3C coupled to deliverydevice 10 and having sealing member 322 in a partially invertedposition. Delivery device 10 may include one or more removable sutures1030 configured to automatically invert sealing member 322 of prostheticheart valve 300. Removable sutures 1030 may extend within a lumen ofouter shaft 22 from compartment 23 to apertures 46 in carriage assembly40 at which the proximal ends of the sutures may be connected. Sutures1030 may take any of the forms and be made of any of the materialsdescribed above with respect to sutures 330. Removable sutures 1030 maybe connected at their distal ends to respective apertures in sealingmember 322 adjacent its free edge 323, and the free ends of each suturemay extend proximally to operating handle 20 through outer shaft 22 ofdelivery device 10.

Sutures 1030 may have proximal end portions 1032 that are connected toapertures 46 in carriage assembly 40, thereby fixing the end portions ofthe sutures to the carriage assembly for movement therewith. Endportions 1032 may be accessible for a user holding operating handle 20to cut after inversion of sealing member 322.

As shown in FIG. 10A, proximal end portions 1032 of sutures 1030 may betake the form of a single looped suture portion that extends aroundhemostasis valve 28. In one example, proximal end portions 1032 ofsutures 1030 may each terminate in a knot that is wider than theapertures 46, such that the apertures may retain the proximal endportions in a fixed relationship to carriage assembly 40. In anotherexample, proximal end portions 1032 of sutures 1030 may be a singlesuture portion that extends between apertures 46 without extendingaround hemostasis valve 28. In other examples, end portions 1032 ofsutures 1030 may take any other form that permits a user access to thesutures for cutting and/or removal of the sutures from the deliverydevice 10, and fixes the sutures to the carriage assembly 40, so thatthe sutures may be pulled together with the carriage assembly.

To use operating handle 20 to deploy a prosthetic valve that has beenloaded into the compartment 23 and covered by distal sheath 24, the usermay rotate deployment actuator 21, causing carriage assembly 40 to slideproximally within elongated space 34 in housing 30. Because distalsheath 24 is affixed to outer shaft 22, which in turn is affixed to thecarriage assembly 40, and because inner shaft 26 is fixed to housing 30,sliding the carriage assembly proximally relative to the housing willretract the distal sheath proximally from compartment 23, therebyexposing and initiating deployment of the valve located therein.

Because end portions 1032 of sutures 1030 are affixed to carriageassembly 40 for movement therewith, as distal sheath 24, outer shaft 22,and the carriage assembly are moved proximally, the sutures pull freeedge 323 of sealing member 322 in the longitudinal direction L towardproximal end 12 of delivery device 10. This pulling of sutures 1030causes sealing member 322 to automatically (i.e., without the userpulling the sutures independently of moving the carriage assembly) beginto move from the extended condition (FIG. 3A) to the inverted condition(FIG. 3B).

When the deployment procedure has reached a partial deployment of thevalve, for example, deployment of about 80% of the length of the valve,the user can evaluate the position of the valve relative to thepatient's aortic annulus and may be able to determine whether the valveis functioning properly. If repositioning or removal is desired, theuser may resheath the valve, for example, by rotating deploymentactuator 21 in the direction opposite that used for deployment. Suchrotation will cause threaded rod 36 to progress distally throughdeployment actuator 21 until carriage assembly 40 has reached thestarting position shown in FIG. 10B, thereby re-collapsing the expandedpart of the valve as distal sheath 24 is moved distally over compartmentand the partially deployed valve. With the valve resheathed, the usercan reposition delivery device 10 and commence the deployment procedureonce again or simply remove the valve from the patient.

Once the proper positioning of the valve relative to the aortic annulushas been assured, the user may complete the deployment process. The usercan slide carriage assembly 40 proximally to complete the deployment ofthe valve by again rotating deployment actuator 21 in the firstdirection, thereby releasing the valve from catheter assembly 16. Withdistal sheath 24 completely withdrawn from the compartment, and carriageassembly 40 at its proximalmost position (FIG. 10A), sealing member 322will be in the inverted condition. After sealing member 322 has beeninverted, a user may cut end portions 1032 of sutures 1030 that extendthrough apertures 46 of carriage assembly 40. The user may then pull oneend of each suture 1030 proximally until the suture withdraws fromsealing member 322 and from apertures 46 of carriage assembly 40.

Although the automatic sealing member inversion has been described abovewith respect to inverting the sealing member of prosthetic heart valve300 of FIG. 3A, that arrangement may be used to invert the sealingmembers of any of the other prosthetic heart valves described herein.

FIG. 11 illustrates heart valve 1100, which is the same as heart valve800 of FIGS. 8A and 8B, except that sealing member of 1122 of heartvalve 1100 includes removable pegs 1128 that hold the sealing member inits initial extended condition until a user decides to move the sealingmember to an inverted or contracted condition.

Prosthetic heart valve 1100 has energy storage elements 1130 that may bethe filaments 830 described above. Energy storage elements 1130 may havean unstressed length and a shape memory such that, when a longitudinalforce is applied to stretch the energy storage elements to an extendedlength, the energy storage elements have a spring bias that tends toshorten the energy storage elements back to their unstressed length.Energy storage elements 1130 may be made from elastic sutures or anelastomeric member, for example, and preferably are made of abiocompatible material so that they may be left in a patient after thedeployment of prosthetic heart valve 1100.

Removable pegs 1128 are configured to hold sealing member 1122 is itsinitial extended condition, such as the extended condition shown in FIG.11. Pegs 1128 may be rigid reinforcements removably attached to sealingmember 1122 that prevent the sealing member from folding to an invertedcondition (e.g., FIG. 8B) or a contracted condition (e.g., FIG. 8C)until the pegs are detached from the sealing member by a user. Pegs 1128are affixed to filaments 1129 (e.g., wires, sutures, or any of the otherfilamentary structures described above) that may extend from the pegsproximally to a delivery device handle, where they may be accessible fora user to pull.

Pegs 1128 may be removably coupled to sealing member 1122, for example,by filaments such as sutures (not shown) that are configured to breakwhen a threshold amount of force is applied thereto. One filament maycouple a peg 1128 to sealing member 1122 adjacent free edge 1123, andanother filament may couple the peg to the sealing member adjacentproximal end 1113 of cuff 1112. Alternatively, pegs 1128 may beremovably coupled to sealing member 1122 by having each end of the pegengaged in a corresponding pocket (not shown) of the sealing member, forexample, having one pocket adjacent free edge 1123 and another pocketadjacent proximal end 1113 of cuff 1112. As shown in FIG. 11, filaments1129 are affixed to the distal ends of pegs 1128, however, in otherembodiments, the filaments may be attached to other portions of thepegs.

When a user decides to move sealing member 1122 to an inverted condition(e.g., FIG. 8B) or a contracted condition (e.g., FIG. 8C), the user maygrasp and pull the proximal ends of filaments 1129 in a proximaldirection. The proximal force exerted on the pegs 1128 will detach thepegs from sealing member 1122, thereby permitting energy storageelements 1130 to move the sealing member to the inverted or contractedposition, in a manner similar to that described above with reference toFIG. 8B or 8C. Once pegs 1128 have been detached from sealing member1122, the user may advance the distal sheath of the delivery device(e.g., similar to the delivery device 10 shown in FIGS. 10A and 10B), atwhich point the pegs and the ends of filaments 1129 attached to the pegsare captured in the valve compartment, so that the pegs will not damagenative tissue of the patient during withdrawal of the delivery devicefrom the patient.

Pegs 1128 are preferably removed from sealing member 1122 before aorticend 1132 of prosthetic heart valve 1100 is fully radially expanded inorder to eliminate the need to force the pegs between the aortic end ofthe valve and native tissue of the ascending aorta, potentiallyresulting in damage to the native tissue.

Although prosthetic heart valve 1100 is described as a variation ofprosthetic heart valve 800 of FIGS. 8A and 8B, prosthetic heart valve1100 may alternatively be a variation of prosthetic heart valve 900 ofFIGS. 9A and 9B. In such a variation, the function of energy storageelements 1130 may be replaced by the energy storage function ofindependent fingers 911, which have a shape memory that tends to rollthe fingers into the spiral shape shown in FIG. 9B when the fingers arenot being held in a substantially straight configuration. In thisvariation, when pegs 1128 are detached from sealing member 1122,independent fingers 911 will be free to assume a rolled conditionaccording to their bias, rolling the sealing member to form a sealingring (as shown in FIG. 9B).

FIGS. 12A-12C illustrate prosthetic heart valve 1200, which is avariation of prosthetic heart valve 1100 of FIG. 11 including a sealingmember having an alternate version of the removable pegs. Prostheticheart valve 1200 includes sealing member 1222 that has removable pegs1228 that are configured to hold the sealing member in its initialextended condition (FIG. 12A) until a user decides to move the sealingmember to a contracted condition (FIGS. 12B and 12C). Similar to pegs1128, pegs 1228 may be rigid reinforcements removably attached tosealing member 1222 that prevent the sealing member from folding to aninverted condition (e.g., FIG. 8B) or a contracted condition (e.g., FIG.8C) until the pegs are detached from the sealing member by a user.

Prosthetic heart valve 1200 has energy storage elements that may be thesame as those described above with respect to FIG. 11, although thoseenergy storage elements are not shown in FIGS. 12A-12C. The energystorage elements are configured to move sealing member 1222 from itsinitial extended condition to its contracted condition.

Pegs 1228 are configured to hold sealing member 1222 is its initialextended condition, such as the extended condition shown in FIG. 12A.Similar to pegs 1128, pegs 1228 may be removably coupled to sealingmember 1222, for example, by filaments such as sutures that areconfigured to break when a threshold amount of force is applied thereto,or by having each end of the peg engaged in a corresponding pocket ofthe sealing member.

Pegs 1228 are affixed to springs 1229 that may extend from the pegsproximally to their fixation to distal sheath 24 of a delivery device,such as delivery device 10 of FIGS. 10A and 10B. Proximal end 1221 ofeach spring 1229 is affixed to distal sheath 24, so that when the distalsheath is moved proximally by the user to deploy the prosthetic heartvalve 1200 within a patient, the springs are stretched in the directionof the longitudinal axis of the distal sheath.

When the pulling force acting on pegs 1228 reaches a predeterminedthreshold amount, springs 1229 automatically (i.e., without the userpulling the springs independently of moving the distal sheath 24) detachthe pegs from sealing member 1222, thereby permitting the energy storageelements to move the sealing member from the extended condition to thecontracted condition, in a manner similar to that described above withreference to FIG. 8C. After pegs 1228 have been detached from sealingmember 1222, springs 1229 automatically pull the pegs into distal sheath24, as shown in FIG. 12C. Once pegs 1228 have been pulled into distalsheath 24 and the distal sheath has been moved to cover the valvecompartment, the pegs will not damage native tissue of the patientduring withdrawal of the delivery device from the patient.

Although prosthetic heart valve 1200 is shown as having a sealing member1222 that is configured to move from an extended condition to acontracted condition similar to that shown in FIG. 8C, springs 1229 andpegs 1228 may also be used with prosthetic heart valves that areconfigured to move from an extended condition to an inverted condition,such as that shown in FIG. 8B.

FIG. 13A illustrates prosthetic heart valve 1300 a and delivery device1310 a, which is substantially the same as prosthetic heart valve 300and delivery device 10 of FIGS. 10A-10C. Delivery device 1310 a includessutures 1330 a that extend through catheter assembly 1316 a fromprosthetic heart valve 1300 a to handle 1320 a. Handle 1320 a mayinclude a cutting mechanism (not shown) that is configured to cut endportions 1332 a of sutures 1330 a after inversion of sealing member 1322a. After end portions 1332 a are cut, a user may grasp one end of eachsuture 1330 a and pull the suture proximally to withdraw the suture fromdelivery device 1310 a.

FIG. 13B illustrates prosthetic heart valve 1300 b and delivery device1310 b, which is another variation of prosthetic heart valve 300 anddelivery device 10 of FIGS. 10A-10C. Delivery device 1310 b includessutures 1330 b that extend through shaft 1328 within catheter assembly1316 b from prosthetic heart valve 1300 b to handle 1320 b. Shaft 1328,which may extend through catheter assembly 1316 b, may have a sharpdistal end that is configured to cut sutures 1330 a when the shaft ismoved distally by a user after inversion of sealing member 1322 a.Although FIG. 13B illustrates an example of a shaft 1328 having a sharpdistal end, in other examples, the catheter assembly 1316 b may includeother types of cutting mechanisms. Portions of sutures 1330 a may remainin the patient with the prosthetic heart valve 1300 b instead of beingremoved. Such sutures 1330 a may be biodegradable.

FIGS. 14A and 14B illustrate a prosthetic heart valve 1400 that is avariation of prosthetic heart valve 300 of FIGS. 3A-3C. Prosthetic heartvalve 1400 has one or more filaments 1430, each filament having a coiledportion 1432 extending through a respective aperture in sealing member1422 adjacent its free edge 1423. Each filament 1430 has a proximal endportion (not shown) at an end opposite the coiled portion 1432. Theproximal end portions of filaments 1430 may extend through a catheterassembly to an operating handle, such as operating handle 20 of FIGS.10A and 10B, where the proximal end portions may be available forgrasping by a user. Coiled portions 1432 may each comprise a springsteel coil, or, for example, another filamentary element that has ashape memory.

When a user desires to invert sealing member 1422 from the extendedcondition of FIG. 14A to the inverted condition of FIG. 14B, the usermay grasp the proximal end portions of filaments 1430 and pull the endportions in a proximal direction. At first, the pulling of filaments1430 will cause the sealing member 1422 to invert, because the forcerequired to unwind coiled portions 1432 is sufficiently large that thecoiled portions will not unwind while the sealing member inverts. Theuser may continue to pull the end portions proximally, which will causethe coiled portions 1432 to unwind and withdraw from the respectiveapertures in sealing member 1422. Once the coiled portions 1432 havecompletely decoupled from sealing member 1422, the user may withdrawfilaments 1430 from the delivery device.

FIGS. 15A and 15B illustrate prosthetic heart valve 1500 and deliverydevice 1510, which is a variation of prosthetic heart valve 300 anddelivery device 10 of FIGS. 10A-10C. Delivery device 1510 has one ormore sutures 1530, each suture having a distal end 1532 affixed tosealing member 1522 adjacent its free edge 1523, and a proximal end1534. Each proximal end 1534 may include a loop with opening 1536therein (FIG. 15B). In this embodiment, sutures 1530 remain in a patientwith prosthetic heart valve 1500 instead of being removed. Such sutures1530 may be biodegradable.

Delivery device 1510 includes spring arms 1526 each having a first end1527 pivotally coupled to retainer 1525 and a second end 1528 remotefrom the first end. Second end 1528 of each spring arm 1526 has a hookfeature that forms a radially-inwardly facing acute angle relative tothe rest of the spring arm. When spring arms 1526 are covered by distalsheath 1524, the spring arms are retained within recesses 1529 ofretainer 1525. When spring arms 1526 are uncovered by distal sheath1524, the second ends of the spring arms are configured to automatically(i.e., without actuation by the user independent from actuation ofdistal sheath 1524) pivot away from the retainer according to theirbias.

During deployment of prosthetic heart valve 1500, after distal sheath1524 has uncovered the prosthetic heart valve, sealing member 1522 isinitially in the extended condition with distal sheath covering springarms 1526. In this initial condition, proximal ends 1534 of sutures 1530are removably coupled to spring arms 1526 with second ends 1528 of thespring arms extending into openings 1536 of the sutures.

To invert sealing member 1522, a user may move distal sheath 1524proximally to uncover prosthetic heart valve 1500, so that the heartvalve self-expands in a radial direction. Since sutures 1530 extendalong the outside surface of prosthetic heart valve 1500, the radialexpansion of the prosthetic heart valve will push central portions ofthe sutures radially outward from a longitudinal axis of the valve,thereby shortening the distance between distal end 1532 and proximal end1534 of each suture 1530. Since proximal end 1534 of each suture 1530 iscoupled to delivery device 1510 by a respective spring arm 1526, eachdistal end 1532 will be moved closer to its corresponding proximal end,thereby moving sealing member 1522 to the inverted condition shown inFIG. 15B.

To release sutures 1530 from delivery device 1510, a user may movedistal sheath 1524 further proximally to uncover spring arms 1526, andthe spring arms will automatically pivot outwardly so that second ends1528 are spaced apart from retainer 1525. Once spring arms 1526 havepivoted to the fully outward position shown in FIG. 15B, proximal end1534 of each suture 1530 will slide off the hook feature at second end1528 of the respective spring arm as a result of the continued tensionapplied to the sutures by the spring arms, thereby decoupling thesutures from the spring arms. Before delivery device 1510 is removedfrom the patient, the user may pivot spring arms 1526 back into recesses1529 by moving distal sheath 1524 distally to cover the spring arms.

FIG. 16A illustrates prosthetic heart valve 1600 a and delivery device1610 a, which is a variation of prosthetic heart valve 1500 and deliverydevice 1510 of FIGS. 15A and 15B. Delivery device 1610 a includes one ormore sutures 1630 a, each suture having a distal end 1632 a affixed tosealing member 1622 adjacent its free edge 1623, and a proximal end 1634a. Each proximal end 1634 a may include a loop having an openingtherein.

Delivery device 1610 a includes lateral posts 1626 a each having a firstend 1627 a affixed to retainer 1625 a and a second bulbous end 1628 aremote from the first end. The openings at proximal ends 1634 a ofsutures 1630 a preferably have approximately the same diameter as thebulbous ends 1628 a, so that the proximal ends of the sutures won't falloff of the bulbous ends when lateral posts 1626 a are covered by distalsheath 1624, but a small amount of pulling on the sutures will pull thesutures off of the lateral posts. Therefore, when lateral posts 1626 aare uncovered by distal sheath 1624, proximal ends 1634 a of sutures1630 a are free to slip off of the lateral posts if a radially-outwardforce is applied to the proximal ends of the sutures.

Although bulbous ends 1628 a are shown as having a bulb shape, any shapeof second ends 1628 a may be used that can removably retain proximalends 1634 a of sutures 1630 a on lateral posts 1626 a while distalsheath 1624 is covering the lateral posts, and that can permit theproximal ends of the sutures to be easily pulled off of the lateralposts when the distal sheath uncovers the lateral posts.

During deployment of prosthetic heart valve 1600 a, after distal sheath1624 has uncovered the prosthetic heart valve, sealing member 1622 isinitially in the extended condition with the distal sheath coveringlateral posts 1626 a. In this initial condition, proximal ends 1634 a ofsutures 1630 a are removably coupled to lateral posts 1626 a with thebulbous ends 1628 a of the lateral posts extending through the openingsof the proximal ends of the sutures.

To invert sealing member 1622, a user may move distal sheath 1624proximally to uncover prosthetic heart valve 1600 a, so that the heartvalve self-expands in a radial direction. Since sutures 1630 a extendalong the outside surface of prosthetic heart valve 1600 a, the radialexpansion of the prosthetic heart valve will push central portions ofthe sutures radially outward from a longitudinal axis of the valve,thereby shortening the distance between distal end 1632 a and proximalend 1634 a of each suture 1630 a. Since proximal end 1634 a of eachsuture 1630 a is coupled to delivery device 1610 a by a respectivelateral post 1626 a, each distal end 1632 a will be moved closer to itscorresponding proximal end, thereby moving sealing member 1622 to theinverted condition shown in FIG. 16A.

To release sutures 1630 a from delivery device 1610 a, once sealingmember 1622 has inverted, the user may continue to move distal sheath1624 proximally to uncover lateral posts 1626 a. The continuedradially-outward force applied by prosthetic heart valve 1600 a tocentral portions of sutures 1630 a will push proximal ends 1634 a of thesutures off of lateral posts 1626 a, thereby decoupling the valve fromdelivery device 1610 a. In this embodiment, sutures 1630 a remain in apatient with prosthetic heart valve 1600 a instead of being removed.Such sutures 1630 a may be biodegradable.

FIG. 16B illustrates a prosthetic heart valve 1600 b that is a variationof prosthetic heart valve 1600 a of FIG. 16A. Prosthetic heart valve1600 b is the same as prosthetic heart valve 1600 a, except thatprosthetic heart valve 1600 b has sutures 1630 b that extend throughopenings 1669 in stent retaining elements 1668 during the path from freeedge 1623 of sealing member 1622 to the retainer of a delivery device,such as delivery device 1610 a of FIG. 16A. Since sutures 1630 b extendthrough openings 1669 in stent retaining elements 1668, when prostheticheart valve 1600 b is uncovered and radially self-expands, the suturesmay more easily maintain their circumferentially-spaced positions aboutthe valve. Such a configuration may result in a more reliable andrepeatable inversion of sealing member 1622 than the embodiment of FIG.16A. In such embodiment, when sutures 1630 b are detached as describedabove in the previous embodiment, the sutures remain attached toprosthetic heart valve 1600 b and may biodegrade over time.

FIG. 16C illustrates prosthetic heart valve 1600 c and delivery device1610 c, which is another variation of prosthetic heart valve 1500 anddelivery device 1510 of FIGS. 15A and 15B. Delivery device 1610 c hasone or more sutures 1630 c, each suture having a distal end 1632 caffixed to sealing member 1622 adjacent its free edge 1623, and aproximal end 1634 c. Each proximal end 1634 c may form a loop having anopening therein.

Delivery device 1610 c includes one or more coiled filaments 1626 chaving a first end 1627 c affixed to retainer 1625 c and a second freeend 1628 c at the end of the coil. The coiled filament 1626 c maycomprise a spring steel coil, or, for example, another filamentaryelement that has a shape memory.

During deployment of prosthetic heart valve 1600 c, sealing member 1622is initially in the extended condition with distal sheath 1624 coveringthe valve. In this initial condition, proximal ends 1634 c of sutures1630 c are removably coupled to one or more coiled filaments 1626 c withfree ends 1628 c of the coiled filaments extending into the openings atthe proximal ends of the sutures.

To invert sealing member 1622, a user may move distal sheath 1624proximally to uncover prosthetic heart valve 1600 c, so that the heartvalve self-expands in a radial direction. Since sutures 1630 c extendalong the outside of prosthetic heart valve 1600 c, the radial expansionof the prosthetic heart valve will push central portions of the suturesradially outward from the longitudinal axis of the valve, therebyshortening the distance between distal end 1632 c and proximal end 1634c of each suture 1630 c. Since proximal ends 1634 c of sutures 1630 care coupled to delivery device 1610 c by one or more coiled filaments1626 c, each distal end 1632 a will be moved closer to its correspondingproximal end, thereby moving sealing member 1622 to the invertedcondition shown in FIG. 16C.

Once sealing member 1622 has inverted, the user may decouple proximalends 1634 c of sutures 1630 c from the one or more coiled filaments 1626c by pulling delivery device 1610 c in a proximal direction. Because thefrictional force between prosthetic heart valve 1600 c and the nativeanatomy will be greater than the force required to unwind coiledfilaments 1626 c, as the user pulls delivery device 1610 c proximally,the coiled filaments will unwind and withdraw from the openings inproximal ends 1634 c of sutures 1630 c, thereby decoupling the valvefrom the delivery device.

FIG. 17 illustrates prosthetic heart valve 1700, which is a variation ofprosthetic heart valve 1600 c of FIG. 16C. Prosthetic heart valve 1700is the same as prosthetic heart valve 1600 c, except that sutures 1730include coiled links 1726 in a central portion thereof.

Each suture 1730 has a distal portion 1730 a extending between free edge1723 of sealing member 1722 and a first end 1727 of a correspondingcoiled link 1726, and a proximal portion 1730 b extending between asecond end 1728 of the corresponding coiled link 1726 and the retainerof a delivery device, such as delivery device 1610 c. The distal portion1730 a of suture 1730 forms a loop having an opening therein that isconfigured to have first end 1727 of coiled link 1726 extendtherethrough. Proximal portion 1730 b of suture 1730 also forms a loophaving an opening therein that is configured to have second end 1728 ofcoiled link 1726 extend therethrough. Each coiled link 1726 may comprisea portion of a spring steel coil.

To ensure that link 1726 may disengage from distal portion 1730 a ofsuture 1730 to release prosthetic heart valve 1700 from a deliverydevice, second end 1728 of the link may be fixedly connected to proximalportion 1730 b of the suture, for example, using an adhesive.Alternatively, second end 1728 of link 1726 may form a closed loop ormay incorporate a boss having a width greater than a diameter of thelooped end of proximal portion 1730 b of suture 1730, such that theproximal portion of the suture may be fixedly retained on the second endof the link.

The deployment of prosthetic heart valve 1700 is performed identicallyto the deployment of prosthetic heart valve 1600 c described above,except that once sealing member 1722 has inverted, the user may decoupledistal portions 1730 a of sutures 1730 from the corresponding coiledlinks 1726 by pulling the delivery device in a proximal direction.Because the frictional force between the prosthetic heart valve 1700 andthe native anatomy will be greater than the force required to unwindfirst end 1727 of coiled links 1726, as the user pulls the deliverydevice proximally, the first ends of the coiled links will unwind andwithdraw from the openings in distal portions 1730 a of sutures 1730,thereby decoupling the valve from the delivery device.

FIGS. 18A-18C illustrate a prosthetic heart valve 1800 that is avariation of prosthetic heart valve 300 of FIGS. 3A-3C. Prosthetic heartvalve 1800 has stent portion 1806 configured to be deployed within thenative aortic annulus of a patient, and an expandable anchor portion1801 configured to be deployed within the ascending aorta as shown inFIG. 18C. Anchor portion 1801 may have covering 1802 made of a porousfabric suitable for tissue ingrowth, for example.

Prosthetic heart valve 1800 has one or more filaments 1830 (e.g., wires,sutures, or any of the other filamentary structures described above)each having a first end 1831 affixed to sealing member 1822 adjacent itsfree edge 1823, and a second end 1832 affixed to anchor portion 1801.When prosthetic heart valve 1800 is in its expanded state, anchorportion 1801 retains sealing member 1822 in its inverted condition viafilaments 1830 extending between the anchor portion and stent portion1806. In one embodiment, filaments 1830 may take the form of sutures.Filaments 1830 may be biodegradable sutures that may dissolve oncetissue ingrowth is sufficient to retain anchor portion 1801 and stentportion 1806 in their deployed locations.

During deployment of prosthetic heart valve 1800, sealing member 1822 isinitially in the extended condition shown in FIG. 18A with the distalsheath of a delivery device (e.g., the delivery device 10 of FIGS. 10Aand 10B) covering stent portion 1806 and anchor portion 1801. To deploystent portion 1806, a user may move the distal sheath proximally touncover prosthetic heart valve 1800, so that the heart valveself-expands in a radial direction, while anchor portion 1801 remainscovered by the distal sheath.

To invert sealing member 1822, the user may pull the delivery device ina proximal direction. Because the frictional force between stent portion1806 and the native anatomy will be greater than the force required toinvert sealing member 1822, as the user pulls the delivery deviceproximally, sutures 1830 will move the sealing member to the invertedcondition shown in FIGS. 18B and 18C.

Once sealing member 1822 has been inverted, the user may deploy anchorportion 1801 by continuing to move the distal sheath proximally touncover the anchor portion, so that the anchor portion self-expands in aradial direction. Once anchor portion 1801 has been deployed, thedelivery device may be removed from the patient.

Although various sealing structures have been described herein as“sealing rings,” it is to be understood that the term “sealing ring” asused herein may describe one or more discontinuous sealing structuresthat do not completely extend around the circumference of the stent of aprosthetic heart valve.

Although many of the embodiments herein have been described as havingsutures, any of such sutures may be replaced with other filamentaryelements, such as at least one polymer wire, braided metal wire, Nitinolwire, cord, ribbon, or any other connecting member that may be used topull the corresponding sealing member to an inverted condition or acontracted condition.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

In summary, the disclosure herein recites multiple embodiments.Described herein is a prosthetic heart valve configured to be expandedproximate a native valve of a patient. The prosthetic heart valve mayinclude a collapsible and expandable stent having a proximal end, adistal end, an annulus section adjacent the proximal end, and aplurality of cells connected to one another in a plurality of annularrows around the stent, a cuff attached to the annulus section of thestent and defining an outward-facing surface, a plurality of prostheticvalve leaflets attached to the cuff, and a sealing member attached tothe cuff and extending from a proximal end of the cuff to a free edge.The stent may have a flow direction extending from the proximal end ofthe stent toward the distal end of the stent. The sealing member may bemovable between an extended condition in which the free edge is locatedproximally of the proximal end of the stent, and an inverted conditionin which the free edge is located distally of the proximal end of thestent and a first surface of the sealing member confronts theoutward-facing surface of the cuff; and/or

the sealing member in the extended condition may be located entirelybelow the proximal end of the stent; and/or

the sealing member in the inverted condition may extend continuouslyaround a circumference of the stent; and/or

the prosthetic heart valve may also include a sealing ring attached to asecond surface of the sealing member opposite the first surface, whereinin the inverted condition of the sealing member and in an expanded usecondition of the stent, the sealing ring may have a diameter greaterthan a diameter of the proximal end of the stent; and/or

in the extended condition of the sealing member, the sealing ring may belocated entirely proximally of the proximal end of the stent; and/or

the prosthetic heart valve may also include a stored energy elementinside the sealing ring, wherein in the inverted condition of thesealing member the stored energy element is biased to provide a force toan outer edge of the sealing ring in a direction orthogonal to the flowdirection when the outer edge is radially compressed; and/or

the stored energy element may include a spring that extends in at leastone complete loop about a circumference of the sealing ring; and/or

the prosthetic heart valve may also include a plurality of retractablewires extending between a first position on the stent and a secondposition near the free edge of the sealing member, the retractable wireshaving a first length in the extended condition of the sealing memberand a second length in the inverted condition of the sealing member, thesecond length being shorter than the first length.

Also described herein is another prosthetic heart valve configured to beexpanded proximate a native valve of a patient. The prosthetic heartvalve may include a collapsible and expandable stent having a proximalend, a distal end, an annulus section adjacent the proximal end, and aplurality of cells connected to one another in a plurality of annularrows around the stent, a cuff attached to the annulus section of thestent and defining an outward-facing surface, a plurality of prostheticvalve leaflets attached to the cuff, and a sealing member attached tothe cuff and extending from a proximal end of the cuff to a free edge.The stent may have a flow direction extending from the proximal end ofthe stent toward the distal end of the stent. The sealing member may bemovable between an extended condition in which the free edge is locateda first distance proximally of the proximal end of the stent, and acompressed condition in which the free edge is located a second distanceproximally of the proximal end of the stent; and/or

in the compressed condition of the sealing member and in an expanded usecondition of the stent, the sealing member may have a diameter greaterthan a diameter of the proximal end of the stent; and/or

in the compressed condition of the sealing member and in an expanded usecondition of the stent, the sealing member may have a plurality ofalternating peaks and valleys extending in the circumferential directionof the stent, the peaks being located at a greater radial distance awayfrom the stent than the valleys; and/or

in the compressed condition of the sealing member and in the expandeduse condition of the stent, each of the peaks may have an adjacentvalley proximal to at least a portion of the respective peak, and eachof the peaks may have a central portion that extends proximally of therespective adjacent valley.

Also described herein is a method of expanding a prosthetic heart valveproximate a native valve of a patient. The prosthetic heart valve mayinclude a stent having proximal and distal ends, a cuff attached to thestent, and a sealing member extending from a proximal end of the cuff toa free edge.

The method may include collapsing the prosthetic heart valve into adelivery device such that the sealing member is in an extended conditionin which the free edge is located proximally of the proximal end of thestent, inserting the delivery device into a patient, advancing thedelivery device proximate an annulus of the native valve, partiallyexpanding the prosthetic heart valve in a selected position proximatethe native valve, moving the sealing member from the extended conditionto an inverted condition in which the free edge is located distally ofthe proximal end of the stent, and fully expanding the prosthetic heartvalve; and/or

the sealing member in the extended condition may be located entirelyproximally of the proximal end of the stent; and/or

the sealing member may include wires extending from the free end of thesealing member through the delivery device to a location outside thepatient, and the moving step may include pulling the wires to move thefree edge of the sealing member; and/or

the method may also include withdrawing the wires from the patient whileleaving the prosthetic heart valve inside the patient; and/or

after the moving step, a first surface of the sealing member mayconfront an outward-facing surface of the cuff; and/or

the prosthetic heart valve may also include a sealing ring attached to asecond surface of the sealing member opposite the first surface, and themoving step may include inverting the sealing ring from an inward-facingcondition to an outward-facing condition in which the sealing ring has adiameter greater than a diameter of the proximal end of the stent;and/or

in the extended condition of the sealing member, the sealing ring may belocated entirely proximally of the proximal end of the stent; and/or

the sealing member may include wires extending between a first positionon the stent and a second position near the free edge of the sealingmember, the collapsing step may include extending the wires to a firstlength, and the moving step may include contracting the wires to asecond length shorter than the first length.

Also described herein is a system including a delivery device and aprosthetic heart valve. The delivery device may include an operatinghandle and a catheter assembly. The catheter assembly may include afirst shaft around which a compartment is defined, the first shaft beingoperatively connected to the operating handle, and a distal sheath atleast partially surrounding the first shaft, the distal sheath beingmoveable between a closed condition covering the compartment and an opencondition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. Theprosthetic valve may include a collapsible and expandable stent, a cuff,and a sealing member attached to the cuff. The stent may have a proximalend, a distal end, and an annulus section adjacent the proximal end, thestent having a flow direction extending from the proximal end toward thedistal end. The cuff may be attached to the annulus section of the stentand may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a freeedge, the sealing member being movable between an extended condition inwhich the free edge is located at a first location proximally of theproximal end of the stent, and a use condition in which the free edge islocated at a second location distally of the first location and a firstsurface of the sealing member confronts the outward-facing surface ofthe cuff. The sealing member may have an energy storage element with abias to move the sealing member toward the use condition. The catheterassembly may have a restraining member removably coupled to the sealingmember to hold the sealing member in the extended condition against thebias of the energy storage element; and/or the restraining member may bea peg affixed to a wire, the wire extending through the catheterassembly to the operating handle; and/or

the restraining member may be a peg affixed to a second energy storageelement that extends between the peg and the distal sheath, and thesecond energy storage element may be configured to store energy when thedistal sheath is moved toward the operating handle; and/or therestraining member may be coupled to the valve by filaments that areconfigured to break when the distal sheath is moved toward the operatinghandle beyond a predetermined distance.

Also described herein is another system including a delivery device anda prosthetic heart valve. The delivery device may include an operatinghandle and a catheter assembly. The catheter assembly may include afirst shaft around which a compartment is defined, the first shaft beingoperatively connected to the operating handle, and a distal sheath atleast partially surrounding the first shaft, the distal sheath beingmoveable between a closed condition covering the compartment and an opencondition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. Theprosthetic valve may include a collapsible and expandable stent, a cuff,and a sealing member attached to the cuff. The stent may have a proximalend, a distal end, and an annulus section adjacent the proximal end, thestent having a flow direction extending from the proximal end toward thedistal end. The cuff may be attached to the annulus section of the stentand may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a freeedge, the sealing member being movable between an extended condition inwhich the free edge is located at a first location proximally of theproximal end of the stent, and a use condition in which the free edge islocated at a second location distally of the first location and a firstsurface of the sealing member confronts the outward-facing surface ofthe cuff. The catheter assembly may have an actuating filament having aportion removably coupled to the sealing member and configured to movethe sealing member from the extended condition to the use condition whenthe portion of the actuating filament is moved toward the operatinghandle; and/or

the actuating filament may be configured to move the sealing member fromthe extended condition to the use condition when the entire actuatingfilament is pulled toward the operating handle; and/or

the actuating filament may be configured to move the sealing member fromthe extended condition to the use condition when the portion of theactuating filament is moved toward the operating handle by a firstdistance, and may be configured to decouple from the sealing member whenthe portion of the actuating filament is moved toward the operatinghandle by a second distance greater than the first distance; and/or

the actuating filament may include a coiled spring portion that isconfigured to unwind when the portion of the actuating filament is movedtoward the operating handle by the second distance; and/or

the actuating filament may include a proximal portion operativelycoupled to the distal sheath, and a distal portion operatively coupledto the sealing member, and the coiled spring portion may removablycouple the proximal portion to the distal portion.

Also described herein is another system including a delivery device anda prosthetic heart valve. The delivery device may include an operatinghandle and a catheter assembly. The catheter assembly may include afirst shaft around which a compartment is defined, the first shaft beingoperatively connected to the operating handle, and a distal sheath atleast partially surrounding the first shaft, the distal sheath beingmoveable between a closed condition covering the compartment and an opencondition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. Theprosthetic valve may include a collapsible and expandable stent, a cuff,and a sealing member attached to the cuff. The stent may have a proximalend, a distal end, and an annulus section adjacent the proximal end, thestent having a flow direction extending from the proximal end toward thedistal end. The cuff may be attached to the annulus section of the stentand may define an outward-facing surface.

The sealing member may extend from a proximal end of the cuff to a freeedge, the sealing member being movable between an extended condition inwhich the free edge is located at a first location proximally of theproximal end of the stent, and a use condition in which the free edge islocated at a second location distally of the first location and a firstsurface of the sealing member confronts the outward-facing surface ofthe cuff. The catheter assembly may have an actuating filament removablycoupled to a retaining element of the catheter assembly and configuredto move the sealing member from the extended condition to the usecondition when a portion of the actuating filament is moved toward theoperating handle; and/or

a proximal end of the actuating filament may be removably coupled to thedelivery device, and the actuating filament may be configured to movethe sealing member from the extended condition to the use condition whenthe portion of the actuating filament is moved toward the proximal endof the actuating filament; and/or

the delivery device may also include a cutting tool configured todecouple at least a portion of the actuating filament from the retainingelement, the portion of the actuating filament being biodegradable;and/or

the retaining element may be a pivotable arm configured to retain aproximal end of the actuating filament when the arm is covered by thedistal sheath, and to release the proximal end of the actuating filamentwhen the distal sheath is moved proximally to uncover the arm; and/or

the retaining element may be a post extending away from the first shaftin a lateral direction of the catheter assembly, the post beingconfigured to retain a proximal end of the actuating filament when thepost is covered by the distal sheath and configured to release theproximal end of the actuating filament when the distal sheath is movedproximally to uncover the post.

Also described herein is another system including a delivery device anda prosthetic heart valve. The delivery device may include an operatinghandle and a catheter assembly. The catheter assembly may include afirst shaft around which a compartment is defined, the first shaft beingoperatively connected to the operating handle, and a distal sheath atleast partially surrounding the first shaft, the distal sheath beingmoveable between a closed condition covering the compartment and an opencondition uncovering the compartment for deployment of the valve.

The prosthetic heart valve may be mounted in the compartment. Theprosthetic valve may include a collapsible and expandable stent, a cuff,a sealing member attached to the cuff, an expandable anchor portionhaving a generally cylindrical shape, and an actuating filament. Thestent may have a proximal end, a distal end, and an annulus sectionadjacent the proximal end, the stent having a flow direction extendingfrom the proximal end toward the distal end. The cuff may be attached tothe annulus section of the stent and may define an outward-facingsurface.

The sealing member may extend from a proximal end of the cuff to a freeedge, the sealing member being movable between an extended condition inwhich the free edge is located at a first location proximally of theproximal end of the stent, and a use condition in which the free edge islocated at a second location distally of the first location and a firstsurface of the sealing member confronts the outward-facing surface ofthe cuff. The actuating filament may extend between the free edge of thesealing member and the expandable anchor portion, the actuating filamentconfigured to move the sealing member from the extended condition to theuse condition when the expandable anchor portion is moved toward theoperating handle; and/or

the anchor portion may comprise a covering including a porous materialconfigured to receive tissue ingrowth; and/or

the sealing member may include a porous material configured to receivetissue ingrowth, and the actuating filament may be biodegradable.

Also described herein is a method of expanding a prosthetic heart valveproximate a native valve of a patient. The prosthetic heart valve mayinclude a stent having proximal and distal ends, a cuff attached to thestent, and a sealing member extending from a proximal end of the cuff toa free edge.

The method may include collapsing the prosthetic heart valve into adelivery device such that the sealing member is in an extended conditionin which the free edge is located proximally of the proximal end of thestent, inserting the delivery device into a patient, advancing thedelivery device proximate an annulus of the native valve, expanding theprosthetic heart valve from a first diameter to a second diametergreater than the first diameter in a selected position proximate thenative valve, and moving the sealing member from the extended conditionto a use condition in which the free edge is located at a secondlocation distally of the first location; and/or

the steps of expanding the prosthetic heart valve and moving the sealingmember may be performed simultaneously; and/or

the step of moving the sealing member may be performed by removing arestraining member from the sealing member to permit an energy storageelement of the sealing member to move the sealing member to the usecondition; and/or

the step of moving the sealing member may be performed by moving aportion of an actuating filament toward an operating handle of thedelivery device by a first distance; and/or

the method may also include decoupling the actuating filament from theprosthetic heart valve by moving the portion of the actuating filamenttoward the operating handle by a second distance greater than the firstdistance.

1. A prosthetic heart valve configured to be expanded proximate a nativevalve of a patient, the prosthetic heart valve comprising: a collapsibleand expandable stent having a proximal end, a distal end, an annulussection adjacent the proximal end, and a plurality of cells connected toone another in a plurality of annular rows around the stent, the stenthaving a flow direction extending from the proximal end of the stenttoward the distal end of the stent; a cuff attached to the annulussection of the stent and defining an outward-facing surface; a pluralityof prosthetic valve leaflets attached to the cuff; and a sealing memberattached to the cuff and extending from a proximal end of the cuff to afree edge, the sealing member being movable between an extendedcondition in which the free edge is located proximally of the proximalend of the stent, and an inverted condition in which the free edge islocated distally of the proximal end of the stent and a first surface ofthe sealing member confronts the outward-facing surface of the cuff. 2.The prosthetic heart valve of claim 1, wherein the sealing member in theextended condition is located entirely below the proximal end of thestent.
 3. The prosthetic heart valve of claim 1, wherein the sealingmember in the inverted condition extends continuously around acircumference of the stent.
 4. The prosthetic heart valve of claim 1,further comprising: a sealing ring attached to a second surface of thesealing member opposite the first surface, wherein in the invertedcondition of the sealing member and in an expanded use condition of thestent, the sealing ring has a diameter greater than a diameter of theproximal end of the stent.
 5. The prosthetic heart valve of claim 4,wherein in the extended condition of the sealing member, the sealingring is located entirely proximally of the proximal end of the stent. 6.The prosthetic heart valve of claim 4, further comprising: a storedenergy element inside the sealing ring, wherein in the invertedcondition of the sealing member the stored energy element is biased toprovide a force to an outer edge of the sealing ring in a directionorthogonal to the flow direction when the outer edge is radiallycompressed.
 7. The prosthetic heart valve of claim 6, wherein the storedenergy element includes a spring that extends in at least one completeloop about a circumference of the sealing ring.
 8. The prosthetic heartvalve of claim 1, further comprising: a plurality of retractable wiresextending between a first position on the stent and a second positionnear the free edge of the sealing member, the retractable wires having afirst length in the extended condition of the sealing member and asecond length in the inverted condition of the sealing member, thesecond length being shorter than the first length.
 9. A prosthetic heartvalve configured to be expanded proximate a native valve of a patient,the prosthetic heart valve comprising: a collapsible and expandablestent having a proximal end, a distal end, an annulus section adjacentthe proximal end, and a plurality of cells connected to one another in aplurality of annular rows around the stent, the stent having a flowdirection extending from the proximal end of the stent toward the distalend of the stent; a cuff attached to the annulus section of the stentand defining an outward-facing surface; a plurality of prosthetic valveleaflets attached to the cuff; and a sealing member attached to the cuffand extending from a proximal end of the cuff to a free edge, thesealing member being movable between an extended condition in which thefree edge is located a first distance proximally of the proximal end ofthe stent, and a compressed condition in which the free edge is locateda second distance proximally of the proximal end of the stent.
 10. Theprosthetic heart valve of claim 9, wherein in the compressed conditionof the sealing member and in an expanded use condition of the stent, thesealing member has a diameter greater than a diameter of the proximalend of the stent.
 11. The prosthetic heart valve of claim 9, wherein inthe compressed condition of the sealing member and in an expanded usecondition of the stent, the sealing member has a plurality ofalternating peaks and valleys extending in the circumferential directionof the stent, the peaks being located at a greater radial distance awayfrom the stent than the valleys.
 12. The prosthetic heart valve of claim11, wherein in the compressed condition of the sealing member and in theexpanded use condition of the stent, each of the peaks has an adjacentvalley proximal to at least a portion of the respective peak, and eachof the peaks has a central portion that extends proximally of therespective adjacent valley.
 13. A method of expanding a prosthetic heartvalve proximate a native valve of a patient, the prosthetic heart valveincluding a stent having proximal and distal ends, a cuff attached tothe stent, and a sealing member extending from a proximal end of thecuff to a free edge, the method comprising: collapsing the prostheticheart valve into a delivery device such that the sealing member is in anextended condition in which the free edge is located proximally of theproximal end of the stent; inserting the delivery device into a patient;advancing the delivery device proximate an annulus of the native valve;partially expanding the prosthetic heart valve in a selected positionproximate the native valve; moving the sealing member from the extendedcondition to an inverted condition in which the free edge is locateddistally of the proximal end of the stent; and fully expanding theprosthetic heart valve.
 14. The method of claim 13, wherein the sealingmember in the extended condition is located entirely proximally of theproximal end of the stent.
 15. The method of claim 13, wherein thesealing member includes wires extending from the free end of the sealingmember through the delivery device to a location outside the patient,and the moving step includes pulling the wires to move the free edge ofthe sealing member.
 16. The method of claim 15, further comprising:withdrawing the wires from the patient while leaving the prostheticheart valve inside the patient.
 17. The method of claim 13, wherein,after the moving step, a first surface of the sealing member confrontsan outward-facing surface of the cuff.
 18. The method of claim 17,wherein the prosthetic heart valve further includes a sealing ringattached to a second surface of the sealing member opposite the firstsurface, and the moving step includes inverting the sealing ring from aninward-facing condition to an outward-facing condition in which thesealing ring has a diameter greater than a diameter of the proximal endof the stent.
 19. The method of claim 18, wherein in the extendedcondition of the sealing member, the sealing ring is located entirelyproximally of the proximal end of the stent.
 20. The method of claim 13,wherein the sealing member includes wires extending between a firstposition on the stent and a second position near the free edge of thesealing member, the collapsing step includes extending the wires to afirst length, and the moving step includes contracting the wires to asecond length shorter than the first length.
 21. A system comprising: adelivery device comprising: an operating handle; and a catheterassembly, including: a first shaft around which a compartment isdefined, the first shaft being operatively connected to the operatinghandle; and a distal sheath at least partially surrounding the firstshaft, the distal sheath being moveable between a closed conditioncovering the compartment and an open condition uncovering thecompartment for deployment of the valve; and a prosthetic heart valvemounted in the compartment, the prosthetic valve comprising: acollapsible and expandable stent having a proximal end, a distal end,and an annulus section adjacent the proximal end, the stent having aflow direction extending from the proximal end toward the distal end; acuff attached to the annulus section of the stent and defining anoutward-facing surface; and a sealing member attached to the cuff andextending from a proximal end of the cuff to a free edge, the sealingmember being movable between an extended condition in which the freeedge is located at a first location proximally of the proximal end ofthe stent, and a use condition in which the free edge is located at asecond location distally of the first location and a first surface ofthe sealing member confronts the outward-facing surface of the cuff, thesealing member having an energy storage element with a bias to move thesealing member toward the use condition, wherein the catheter assemblyhas a restraining member removably coupled to the sealing member to holdthe sealing member in the extended condition against the bias of theenergy storage element.
 22. The system of claim 21, wherein therestraining member is a peg affixed to a wire, the wire extendingthrough the catheter assembly to the operating handle.
 23. The system ofclaim 21, wherein the restraining member is a peg affixed to a secondenergy storage element that extends between the peg and the distalsheath, and the second energy storage element is configured to storeenergy when the distal sheath is moved toward the operating handle. 24.The system of claim 21, wherein the restraining member is coupled to thevalve by filaments that are configured to break when the distal sheathis moved toward the operating handle beyond a predetermined distance.25. A system comprising: a delivery device comprising: an operatinghandle; and a catheter assembly, including: a first shaft around which acompartment is defined, the first shaft being operatively connected tothe operating handle; and a distal sheath at least partially surroundingthe first shaft, the distal sheath being moveable between a closedcondition covering the compartment and an open condition uncovering thecompartment for deployment of the valve; and a prosthetic heart valvemounted in the compartment, the prosthetic heart valve comprising: acollapsible and expandable stent having a proximal end, a distal end,and an annulus section adjacent the proximal end, the stent having aflow direction extending from the proximal end toward the distal end; acuff attached to the annulus section of the stent and defining anoutward-facing surface; and a sealing member attached to the cuff andextending from a proximal end of the cuff to a free edge, the sealingmember being movable between an extended condition in which the freeedge is located at a first location proximally of the proximal end ofthe stent, and a use condition in which the free edge is located at asecond location distally of the first location and a first surface ofthe sealing member confronts the outward-facing surface of the cuff,wherein the catheter assembly has an actuating filament having a portionremovably coupled to the sealing member and configured to move thesealing member from the extended condition to the use condition when theportion of the actuating filament is moved toward the operating handle.26. The system of claim 25, wherein the actuating filament is configuredto move the sealing member from the extended condition to the usecondition when the entire actuating filament is pulled toward theoperating handle.
 27. The system of claim 25, wherein the actuatingfilament is configured to move the sealing member from the extendedcondition to the use condition when the portion of the actuatingfilament is moved toward the operating handle by a first distance, andis configured to decouple from the sealing member when the portion ofthe actuating filament is moved toward the operating handle by a seconddistance greater than the first distance.
 28. The system of claim 27,wherein the actuating filament includes a coiled spring portion that isconfigured to unwind when the portion of the actuating filament is movedtoward the operating handle by the second distance.
 29. The system ofclaim 28, wherein the actuating filament includes a proximal portionoperatively coupled to the distal sheath, and a distal portionoperatively coupled to the sealing member, and the coiled spring portionremovably couples the proximal portion to the distal portion.
 30. Asystem comprising: a delivery device comprising: an operating handle;and a catheter assembly, including: a first shaft around which acompartment is defined, the first shaft being operatively connected tothe operating handle; and a distal sheath at least partially surroundingthe first shaft, the distal sheath being moveable between a closedcondition covering the compartment and an open condition uncovering thecompartment for deployment of the valve; and a prosthetic heart valvemounted in the compartment, the prosthetic valve comprising: acollapsible and expandable stent having a proximal end, a distal end,and an annulus section adjacent the proximal end, the stent having aflow direction extending from the proximal end toward the distal end; acuff attached to the annulus section of the stent and defining anoutward-facing surface; and a sealing member attached to the cuff andextending from a proximal end of the cuff to a free edge, the sealingmember being movable between an extended condition in which the freeedge is located at a first location proximally of the proximal end ofthe stent, and a use condition in which the free edge is located at asecond location distally of the first location and a first surface ofthe sealing member confronts the outward-facing surface of the cuff,wherein the prosthetic valve has an actuating filament removably coupledto a retaining element of the catheter assembly and configured to movethe sealing member from the extended condition to the use condition whena portion of the actuating filament is moved toward the operatinghandle.
 31. The system of claim 30, wherein a proximal end of theactuating filament is removably coupled to the delivery device, and theactuating filament is configured to move the sealing member from theextended condition to the use condition when the portion of theactuating filament is moved toward the proximal end of the actuatingfilament.
 32. The system of claim 30, wherein the delivery devicefurther comprises a cutting tool configured to decouple at least aportion of the actuating filament from the retaining element, theportion of the actuating filament being biodegradable.
 33. The system ofclaim 30, wherein the retaining element is a pivotable arm configured toretain a proximal end of the actuating filament when the arm is coveredby the distal sheath, and to release the proximal end of the actuatingfilament when the distal sheath is moved proximally to uncover the arm.34. The system of claim 30, wherein the retaining element is a postextending away from the first shaft in a lateral direction of thecatheter assembly, the post being configured to retain a proximal end ofthe actuating filament when the post is covered by the distal sheath andconfigured to release the proximal end of the actuating filament whenthe distal sheath is moved proximally to uncover the post.
 35. A systemcomprising: a delivery device comprising: an operating handle; and acatheter assembly, including: a first shaft around which a compartmentis defined, the first shaft being operatively connected to the operatinghandle; and a distal sheath at least partially surrounding the firstshaft, the distal sheath being moveable between a closed conditioncovering the compartment and an open condition uncovering thecompartment for deployment of the valve; and a prosthetic heart valvemounted in the compartment, the prosthetic heart valve comprising: acollapsible and expandable stent having a proximal end, a distal end,and an annulus section adjacent the proximal end, the stent having aflow direction extending from the proximal end toward the distal end; acuff attached to the annulus section of the stent and defining anoutward-facing surface; a sealing member attached to the cuff andextending from a proximal end of the cuff to a free edge, the sealingmember being movable between an extended condition in which the freeedge is located at a first location proximally of the proximal end ofthe stent, and a use condition in which the free edge is located at asecond location distally of the first location and a first surface ofthe sealing member confronts the outward-facing surface of the cuff; anexpandable anchor portion having a generally cylindrical shape; and anactuating filament extending between the free edge of the sealing memberand the expandable anchor portion, the actuating filament configured tomove the sealing member from the extended condition to the use conditionwhen the expandable anchor portion is moved toward the operating handle.36. The system of claim 35, wherein the anchor portion comprises acovering including a porous material configured to receive tissueingrowth.
 37. The system of claim 35, wherein the sealing memberincludes a porous material configured to receive tissue ingrowth, andthe actuating filament is biodegradable.
 38. A method of expanding aprosthetic heart valve proximate a native valve of a patient, theprosthetic heart valve including a stent having proximal and distalends, a cuff attached to the stent, and a sealing member extending froma proximal end of the cuff to a free edge, the method comprising:collapsing the prosthetic heart valve into a delivery device such thatthe sealing member is in an extended condition in which the free edge islocated at a first location proximally of the proximal end of the stent;inserting the delivery device into a patient; advancing the deliverydevice proximate an annulus of the native valve; expanding theprosthetic heart valve from a first diameter to a second diametergreater than the first diameter in a selected position proximate thenative valve; moving the sealing member from the extended condition to ause condition in which the free edge is located at a second locationdistally of the first location.
 39. The method of claim 38, wherein thesteps of expanding the prosthetic heart valve and moving the sealingmember are performed simultaneously.
 40. The method of claim 38, whereinthe step of moving the sealing member is performed by removing arestraining member from the sealing member to permit an energy storageelement of the sealing member to move the sealing member to the usecondition.
 41. The method of claim 38, wherein the step of moving thesealing member is performed by moving a portion of an actuating filamenttoward an operating handle of the delivery device by a first distance.42. The method of claim 41, further comprising decoupling the actuatingfilament from the prosthetic heart valve by moving the portion of theactuating filament toward the operating handle by a second distancegreater than the first distance.